Microbiologics Inc recalls
Every recall we track for Microbiologics Inc — 55 in all, from 2017–2025 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Microbiologics Inc more than tripled in 2025 (12, up from 2 in 2024). 2% rated “stop using now”.
All FDA recall records for Microbiologics Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 2 | 3 | 5 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 5 | 0 | 5 |
| 2020 | 0 | 0 | 14 | 4 | 18 |
| 2021 | 0 | 0 | 3 | 1 | 4 |
| 2022 | 0 | 0 | 2 | 4 | 6 |
| 2023 | 1 | 0 | 1 | 1 | 3 |
| 2024 | 0 | 0 | 1 | 1 | 2 |
| 2025 | 0 | 0 | 11 | 1 | 12 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Microbiologics Inc recalls
What to do if you have a recalled Microbiologics Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Microbiologics Inc recalls
36 shown- UnratedMedical device
Microbiologics Inc recalls KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Microbiologics recalls KWIK-STIK 2-Pack products that may fail to recover Campylobacter jejuni subsp. jejuni. Affected units have Catalog Number 0325P and specific lot numbers. No remedy is stated.
MicrobiologicsDec 2, 2025 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Microbiolog: KWIK-STIK culture media kits with lot 818-111-7 may have incorrect labeling. Consumers should check their kit's lot number and contact Microbiologics for details.
MicrobiologicsNov 13, 2025 - Lower riskMedical device
Microbiologics Inc recalls LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
Microbiologics recalls LYFO-DISK products with REF 0894K and 0894P packaging due to risk of failing to recover target microorganisms. Affected lots include 894-76 series.
MicrobiologicsJun 27, 2025 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L
Microbiologics recalls KWIK-STIK and LYFO DISK culture media kits due to potential quality control failure causing delayed patient diagnosis. Affected lots include 805-234-4 and 805-234-5.
MicrobiologicsJun 17, 2025 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿
Microbiologics recalls KWIK-STICK culture media kits with incorrect microorganism packaging, risking delayed diagnosis. Affected kits have specific catalog numbers and lots.
MicrobiologicsMay 27, 2025 - Lower riskMedical device
Microbiologics Inc recalls Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed
Microbiolog: Helix Elite Inactivated Standard (HE0044N) may give late Ct values in RSV testing, causing QC failures. Affected units include specific lot numbers and catalog codes.
MicrobiologicsFeb 20, 2025 - Lower riskMedical device
Microbiologics Inc recalls Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality
Microbiologics recalls Helix Elite Inactivated SARS-CoV-2 Standard due to potential late Ct values in A549 cell testing. Affected units include specific catalog and lot numbers.
MicrobiologicsFeb 20, 2025 - Lower riskMedical device
Microbiologics Inc recalls Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro
Microbiologics recalls HPV control panels with lot 8234-22 due to low HPV 16 L:1 concentration causing invalid test results. Affected users should contact for guidance.
Microbiolog: a short, human brand name for headings (e.g. "Trsmima")Jan 20, 2025 - UnratedMedical device
Microbiologics Inc recalls KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for
Microbiologics recalls KWIK-STIK Rhizopus stolonifer control kits due to contamination with Aspergillus brasiliensis. Users may see A. brasiliensis growth. No remedy specified in recall notice.
MicrobiologicsMar 6, 2024 - Lower riskMedical device
Microbiologics Inc recalls Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Microbiologics recalls Enteric Pathogens Control Panel (REF 8184) due to contaminated negative control causing false Norovirus positives. Affected lots include 8184-65 to 8184-71. No remedy specified.
MicrobiologicsJan 8, 2024 - UnratedMedical device
Microbiologics Inc recalls KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Microbiologics recalls KWIKSTIK P. venetum products (catalog 0794P/0794K) due to Aspergillus flavus contamination in specific lots. Affected items may pose health risks from mold exposure.
MicrobiologicsOct 18, 2023 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing
Microbiologics recalls KWIK-STIK ANA QC Set (Lot 5065-26) due to missing strain 6018P Parabacteroides distasonis in microbiological testing.
MicrobiologicsAug 14, 2023 - UnratedMedical device
Microbiologics Inc recalls Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b.
Microbiologics recalls Helix Elite Inactivated Standard (HE0071N/HE0073N) due to not being registered for UK use. Consumers should check labels for UDI numbers and expiration dates.
MicrobiologicsJul 27, 2022 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK" plus: Clostridium perfringens
Microbiologics recalls KWIK-STIK Plus products with labeling error. Affected items have specific catalog, lot, and expiration numbers. No action needed per recall details.
MicrobiologicsMay 6, 2022 - UnratedMedical device
Microbiologics Inc recalls Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Microbiolog: Inactivated macrolide and quinolone-resistant Mycoplasma genitalium (HE0069N) recalled due to inadequate QC process. No remedy specified in official notice.
MicrobiologicsMar 24, 2022 - UnratedMedical device
Microbiologics Inc recalls Inactivated macrolide-resistant Mycoplasma genitalium
Microbiologics recalls inactivated macrolide-resistant Mycoplas: QC process failed for specification range. No remedy stated in official notice.
MicrobiologicsMar 22, 2022 - Lower riskMedical device
Microbiologics Inc recalls Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 -
Microbiologics recalls Pneumonia (33 Targets) Control Panel due to shorter shelf life than advertised. This quality control material expires in 6 months instead of 18 months.
MicrobiologicsMar 3, 2022 - UnratedMedical device
Microbiologics Inc recalls Mycoplasma genitalium Control Panel (Inactivated Pellet)
Microbiologics recalls specific lots of Mycoplasma genitalium Control Panel (Inactivated Pellet) due to improper release testing. Affected units may not meet safety standards.
MicrobiologicsFeb 25, 2022 - Lower riskMedical device
Microbiologics Inc recalls SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to
Microbiologics recalls SARS-CoV-2 Process Control Swabs contaminated with plasmid DNA containing SARS-CoV-2 sequences. These swabs may cause false positive results in nucleic acid tests.
MicrobiologicsAug 20, 2021 - UnratedMedical device
Microbiologics Inc recalls SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to
Microbiologics recalls SARS-CoV-2 Process Control Pellets with CDC/WHO RNA targets for nucleic acid tests. Recalled lots may pose risks if used incorrectly in testing.
MicrobiologicsAug 20, 2021 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Microbiologics recalls KWIK-STIK IVD controls with potential labeling error in lot 726-57-10. Affected units may have incorrect packaging labels.
MicrobiologicsFeb 24, 2021 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD
Microbiologics recalls KWIK-STIK IVD controls with lot 323-108-7 due to incorrect labeling. Affected units may have wrong product code, but no safety risk is reported. Check your lot number for recall.
MicrobiologicsFeb 24, 2021 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis
Microbiologics recalls KWIK-STIK 2-Packs, 6-Packs, and LYFO DISK due to contamination with S. epidermidis. Affected items have specific catalog numbers and expiration dates.
MicrobiologicsDec 16, 2020 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus
Microbiologics recalls KWIK-STI GBS QC Set (Live Culture) with incorrect expiration date label on negative control component. Affected units have expiration date labeled as 7/31/2020 instead of 7/31/2022. No action required per recall details.
MicrobiologicsDec 16, 2020 - Lower riskMedical device
Microbiologics Inc recalls KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Microbiolog: KWIK-STIK 2-Pack with incorrect lot number 218-234-4 printed on foil pouch. Recalled due to misprint risk of using wrong lot number.
MicrobiologicsOct 8, 2020 - UnratedMedical device
Microbiologics Inc recalls Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating
Microbiolog: KWIK-STIK 6-pack units may contain NDM-1 negative Klebsiella pneumoniae instead of NDM-1 positive strain. This could lead to ineffective treatment for certain infections. Affected units have specific catalog and lot numbers.
MicrobiologicsOct 8, 2020 - Lower riskMedical device
Microbiologics Inc recalls Catalog 02145P, Klebsiella pneumoniae derived from NCTC 13439 - Product Usage: intended to be used as controls to
Microbiologics recalls Catalog 02145P bacterial controls for microbial testing due to incorrect VIM-1 status. These controls may not verify assay performance properly.
MicrobiologicsOct 8, 2020 - UnratedMedical device
Microbiologics Inc recalls KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack;
Microbiologics recalls KWIK-STIK products due to potential contamination with S. epidermidis, E. coli, and S. warneri. Affected units include 2-packs and 6-packs with specific catalog and lot numbers.
MicrobiologicsOct 1, 2020 - Lower riskMedical device
Microbiologics Inc recalls QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro
Microbiologics recalls QC sets and KWIK-STIK AST-GP kits that may return incorrect bacterial susceptibility results, affecting lab testing accuracy.
MicrobiologicsFeb 18, 2020 - Lower riskMedical device
Microbiologics Inc recalls Microbiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing Trichosporon dermatis, ATCC 204094,
Microbiologics recalls QC sets and panels that may contain Candida instead of Trichosporon dermatis, a potential safety risk for lab users.
MicrobiologicsFeb 12, 2020 - Lower riskMedical device
Microbiologics Inc recalls Vaginal Verification Panel Ref 8208 Lot 8208-11
Microbiologics recalls Vaginal Verification Panel Ref 8208 Lot 8208-11 due to Candida krusei contaminant in Pool 2. The recall explains the product's intended use for instrument verification and notes no impact on patient test results if Gardnerella vaginalis is properly detected.
MicrobiologicsJan 3, 2020 - Lower riskMedical device
Microbiologics Inc recalls Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used
Microbiologics recalls Gram-Positive Blood Culture Control Panels (Catalog #8180) due to incorrect hydration fluid specification. This may affect test accuracy in medical labs. No immediate action needed but verify your product model.
MicrobiologicsDec 16, 2019 - Lower riskMedical device
Microbiologics Inc recalls Cepheid Xpert C. difficile/Epi Control Panel
Microbiolog: Cepheid Xpert C. difficile/Epi Control Panel has incorrect expiration date (2021-10-31 vs 2021-03-31). Affected units may expire before intended use.
MicrobiologicsMay 16, 2019 - Lower riskMedical device
Microbiologics Inc recalls Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019,
Microbiologics recalls Cepheid Xpert MRSA/MRSA NxG Control Panels with incorrect shelf life. Affected units have specific catalog numbers and lot ranges. No action needed but check for recall details.
MicrobiologicsApr 9, 2019 - Lower riskMedical device
Microbiologics Inc recalls Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Microbiologics recalls Cepheid Respiratory Control Panel (Catalog #8199) due to reduced expiration date from 24 months to 13 months for in vitro diagnostic use.
MicrobiologicsJan 31, 2019 - UnratedMedical device
Microbiologics Inc recalls Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
Microbiologics recalls Helix Elite Extended Enteric Bacterial Verification Panels due to real-time shelf life testing failure at 24 months. No remedy specified in official notice.
MicrobiologicsJun 6, 2017
Microbiologics Inc recall questions
How many recalls has Microbiologics Inc had?
55 recalls from Microbiologics Inc are on record with U.S. safety agencies, from 2017–2025.
What is the most recent Microbiologics Inc recall?
Microbiologics Inc recalls KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P, dated Dec 2, 2025. Every Microbiologics Inc recall is listed on this page, newest first.
Why are Microbiologics Inc products recalled?
The most common reasons on record: Real-time shelf life testing failed at 24 months (5); Product with incorrect shelf life. (2).
What should I do if I have a recalled Microbiologics Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Microbiologics Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.