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Lower risk Medical device recall · FDA · Published August 18, 2020

Ameditech First Check 7 Panel Drug Cup: Inconsistent Drug Detection Risk

Ameditech recalls First Check 7 Panel Drug Cup (AMP/COC/MDMA/MET/OPI/PCP/THC) due to inconsistent drug detection. All lots within expiry are affected.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3050-2020Medical deviceAmeditech ›
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Recalling firmAmeditech Inc9940 Mesa Rim Rd · San Diego, CA 92121-2910
✎ GovInfoNow plain-language explainer

Ameditech recalls its First Check 7 Panel Drug Cup for inconsistent drug detection results. This means the test may not reliably identify all drugs as labeled, potentially leading to false negatives. Read more at govinfonow.com/recall/64452-ameditech-first-check-7-panel-drug-cup-inconsistent-drug-detection.

Source Summary by GovInfoNow · govinfonow.com/recall/64452-ameditech-first-check-7-panel-drug-cup-inconsistent-drug-detection · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3050-2020

Cite this page

“Ameditech First Check 7 Panel Drug Cup: Inconsistent Drug Detection Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64452-ameditech-first-check-7-panel-drug-cup-inconsistent-drug-detection. Based on FDA recall #Z-3050-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3050-2020%22&limit=1).

The FDA announced on August 18, 2020, that Ameditech Inc voluntarily recalled First Check 7 Panel Drug Cups due to enzyme failures that prevent consistent detection of compounds at labeled levels. The agency issued recall number Z-3050-2020 for the device.

How to tell if you have it

  • Brand: Ameditech
  • Product: First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC)
  • AMT Item Number: 990100B
  • Lots: ALL Lots Within Expiry

The hazard

Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

Context

GovInfoNow's records show Ameditech Inc has issued four other recalls since June 26, 2017. Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (July 6, 2026), Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), and Siemens Atellica CH Urine Albumin Recall (Jan. 20, 2026).

How to tell if you have this one

Check for the First Check 7 Panel Drug Cup with AMP/COC/MDMA/MET/OPI/PCP/THC labels and AMT Item Number 990100B. All lots within expiry are affected.

  • Brand
    Ameditech
  • Category
    Medical device
FDA recall event · 23 products

All 23 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain
Recall numberProduct, codes & lotsQuantity
Z-3029-2020Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)", X11-IS1 BAR-DX /"Alere iScreen" Dx Single Dip Card Single Drug Detection: Barbiturate (BAR)", X11-IS1 OXY-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Oxycodone (OXY)", X11-IS1 BZO-DX / "Alere iScreen" Dx Single Dip Card Single Drug Detection: Benzodiazepine (BZO300)", X11-IS1 MET-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methamphetamine (MET)", X11-IS1 AMP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Amphetamine (AMP)", X11-IS1 MDM-DX / "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Ecstasy (MDMA)", X11-IS1 MTD-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Methadone (MTD)", X11-IS1 MOP-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Morphine (MOP)", X11-IS1 THC-DX/"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Marijuana (THC)", X11-IS1 TCA-DX/ "Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Tricyclic Antidrepessants (TCA)", X11-IS1 PCP-DX /"Alere iScreen¿ Dx Single Dip Card Single Drug Detection: Phencyclidine (PCP)",; ALL Lots Within Expiry303,100 units
Z-3030-2020Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10BUP-DX/ "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100", X11-IS10-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 10 Drug Detection: Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Marijuana, Methadone, Methamphetamine, Morphine, Oxycodone, and Tricyclic Antidepressant", X11-IS5 M-DX /"Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 12 Drug Detection: AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET500+MOP300+OXY100+PCP25+MDMA500+TCA1000", X11-IS5 M-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test 5 Drug Detection: Amphetamine, Cocaine, Marijuana, Methamphetamine, and Morphine", X11-IS10BUP-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test AMP1000+BAR300+BUP10+BZO300+COC300+THC50+MET500+MTD300+MOP300+OXY100"; ALL Lots Within Expiry67,300 units
Z-3031-2020Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup¿ Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."; ALL Lots Within Expiry28,525
Z-3032-2020CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-SDDT-13 /"CLIA Waived" Inc. Single Drug Dipstick Test OPI300, X07-CLIA-SDDT-25/"CLIA Waived" Inc. Single Drug Dipstick Test BUP10, X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-12-RDTC-BUP-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-14-RDTC-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-RDDT-70/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-RDDT-52/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ BZO300/BAR300/MTD300/BUPG10/OXY100", X07-CLIA-RDDT-70/ "CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-RDDT-70/"CLIA Waived" Inc. Rapid Dip Drug Test COC300/OPI300/MET500/THC50/AMP1000/ PCP25/BZO300/BAR300/MTD300/OXY100/ MDMA500", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G., X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G., X07-CLIA-12-RDTC-BUP-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.". X07-CLIA-12-RDTC-BUP-A "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100) + CR, NI, PH, BL, S.G.", X07-CLIA-14-RDTC-A /"CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", X07-CLIA-14-RDTC-A/ "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG", CLIA-14-RDTC-A / "CLIA Waived" Inc. Rapid Drug Test Cup (THC50/COC150)(OPI300/MET500)(AMP500/ BZO300)(BAR300/MTD300)(BUPG10/TCA1000) (MDMA500/OXY100)(PCP25/PPX300) + CR, NI, PH, BL, SG"; ALL Lots Within Expiry120, 150
Z-3033-2020Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",; ALL Lots Within Expiry31,600 units
Z-3034-2020Fastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect¿ II Drug Screen Dipstick Test, 4 Drug Detection: THC50+COC300+OPI300+BZO300", MF20/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: MTD300", MF21/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: TCA1000, MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300, MF18/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BZO300", QF12/ "Fastect¿ II Drug Screen Dipstick Test 4 Drug Detection: THC50+COC300+OPI300+MET500", MF10/ "Fastect¿ II Drug Screen Dipstick Test THC50", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF16 /"Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: MET500", MF23 /"Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF14/ "Fastect¿ II Drug Screen Dipstick Test AMP1000", MF11/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: COC300", MF23 / Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF25/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: BUP10", MF23/ "Fastect¿ II Drug Screen Dipstick Test Single Drug Detection: OXY100"; ALL Lots Within Expiry108,000 units
Z-3035-2020Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, pH, SG)",; ALL Lots Within Expiry31,800 units
Z-3036-2020ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2000+THC50 With Cr, Ni, pH, Bl, S.G.", IMC-8BBCE/ "ImmuTest Drugs of Abuse Cup 8 Drug Detection: (COC300/THC50)+AMP1000+BZO300+BUP10+MET500+MTD300+OPI300 NO ADULTERATION", IMCA-8CM5 /"ImmuTest Drugs of Abuse Cup (OXY100/MDMA500)+(PCP25/AMP1000)+COC150+MET500+OPI2000+THC50 with Cr, Ni, pH, Bl, S.G."; ALL Lots Within Expiry27,375 units
Z-3037-2020MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G. "; ALL Lots Within Expiry23,000 units
Z-3038-2020MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G.", MTPA-6MBAU/ "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH, Bl, S.G."; ALL Lots Within Expiry12, 100 units
Z-3039-2020Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; w/ Cr, Ni, pH, Bl, S.G. Finished Devices", NBCA-14A-PP/"Noble 1 Step + Cup" (THC50/COC150)+(OPI300/MET500)+ (AMP500/BZO300)+(BAR300/MTD300)+ (BOPG10/TCA1000)+(MDMA500/OXY100)+ (PCP25/PPX300) w/ Cr, Ni, pH, Bl, S.G."; ALL Lots Within Expiry13,700 units
Z-3040-2020iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH, Bl, S.G.", X11-I-DX-1147-022 /"iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300)"; ALL Lots Within Expiry136,925 units
Z-3041-2020Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "; ALL Lots Within Expiry1,325 units
Z-3042-2020ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO; ALL Lots Within Expiry51,075 units
Z-3043-2020QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500", QT88/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+ MDMA500+BUP10", QT11 / "QuickTox¿ Drug Screen Dipcard 5 Drug Detection: COC300+OPI2000+THC50+AMP1000+PCP25", QT52/ "QuickTox¿ Drug Screen Dipcard 9 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+MTD300+OXY100", QT44/ "QuickTox¿ Drug Screen Dipcard 8 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+OXY100", QT23/ "QuickTox¿ Drug Screen Dipcard 6 Drug Detection: COC300+OPI2000+MET500+THC50+AMP1000+PCP25", QT80F/ "QuickTox¿ Drug Screen Dipcard 12 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+TCA1000+OXY100+MDMA500 with Positive Control Line", QT52A/ "QuickTox¿ Drug Screen Dipcard 9 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+BZO300+BAR300+MTD300+OXY100 4 Adulteration Test: Cr, Ni, pH, Ox ", QT20/ "QuickTox" Drug Screen Dipcard 5 Drug Detection: COC300+OPI2000+MET500+THC50+AMP1000"; ALL Lots Within Expiry170,425 units
Z-3044-2020TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G."; ALL Lots Within Expiry26,775 units
Z-3045-2020ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100 Adulteration Screen for CR - NI - PH - BL - S.G.", DT14/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300", HT15/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/PCP25/ THC50/OPI2000", HT15A/ ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/PCP25/ THC50/OPI2000 Adulteration Screen for CR - NI - PH - BL - S.G.", PT15/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET500/OPI300/THC50" DT13A/ "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100 w/ Cr, Ni, pH, BI, S.G.", DT14A "ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100; PCP25/PPX300 w/ Cr, Ni, pH, Bl, S.G. Finished Devices", DT12A/"ToxCup¿ Drug Screen Cup THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; PCP25/PPX300 w/ Cr, Ni, pH, BI, S.G.", PT12A/ "ToxCup¿ Drug Screen Cup COC300/MET500/OPI2000/PCP25/THC50 Adulteration Screen for CR - NI - PH - BL - S.G.", PT11A/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/OPI2000/PCP25/THC50 Adulteration Screen for CR - NI - PH - BL - S.G.", HT30/ "ToxCup¿ Drug Screen Cup AMP1000/COC300/MET1000/PCP25/THC50/ OPI2000"; ALL Lots Within Expiry189,175 units
Z-3046-2020First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B; ALL Lots Within Expiry2,555,630 units
Z-3047-2020First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B; ALL Lots Within Expiry47,005 units
Z-3048-2020First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B; ALL Lots Within Expiry41,340 units
Z-3049-2020First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B; ALL Lots Within Expiry537,120 units
Z-3050-2020First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B; ALL Lots Within Expiry99,900 units
Z-3051-2020Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ EDI PPX Uncut Sheet-Card/ 187877, 160130/ EDI COC Uncut Sheet-Cup/ 188168, 160180/ EDI PCP Uncut Sheet-Cup/ 189027, 160140/ EDI THC Uncut Sheet Cup /189028, 160170/ EDI BZO Uncut Sheet-Cup/ 189081, 160120/ EDI MET1000 Uncut Sheet-Cup/ 189082, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189123, 160130/ EDI COC Uncut Sheet-Cup/ 189124, 160160/ EDI OPI2000 Uncut Sheet-Cup/ 189166, 160163/ EDI OPI (300) Uncut Sheet-Cup/ 189191, 160110/ EDI AMP Uncut Sheet-Cup/ 189371, 160140/ EDI THC Uncut Sheet Cup/ 189372, 160123/ EDI MET(300) Uncut Sheet-Cup/ 189425, 160170/ EDI BZO Uncut Sheet-Cup/ 189426, 100163/ EDI OPI (300) Uncut Sheet-Card/ 189456, 160170/ EDI BZO Uncut Sheet-Cup/ 189565, 160180/ EDI PCP Uncut Sheet-Cup/ 189601, 160125/ EDI MET(500) Uncut Sheet-Cup/ 189748, 160130/ EDI COC Uncut Sheet-Cup/ 189786, 160160/ EDI OPI2000 Uncut Sheet-Cup / 189844, 160180/ EDI PCP Uncut Sheet-Cup/ 189937, 160172/ EDI BZO(200) Uncut Sheet-CUP/189956 Updated 09/03/2020: EDI Affected products -Catalog Numbers/ Lot Numbers 31105-3/ PI-01081 60503s-3ZC/ PH-10132 60600/ PH-11005; ALL Lots Within Expiry3600 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by checking for the AMT Item Number 990100B and the drug panel labels.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 4.1 years after the firm started it.

1. Firm started the recall: Aug 18, 202012. FDA classified it Class II: Sep 30, 202023. Published in FDA’s Enforcement Report: Oct 7, 202034. FDA terminated the recall: Sep 30, 2024420202024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3050-2020 (August 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3050-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA