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Lower risk Medical device recall · FDA · Published April 24, 2025

SEKISUI HCG Control Set Recall: Cold Storage Issues May Cause Incorrect Test Results

SEKIS: HCG control set recall due to cold chain disruptions from thunderstorms. Products may give incorrect or delayed test results if stored outside recommended conditions. Check catalog number 138 for affected items.

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

🇺🇸 FDA recall #Z-1854-2025Medical deviceSEKISUI DIAGNOSTICS ›
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Contact the company

Recalling firmMckesson Medical-Surgical Inc. Corporate Office9954 Maryland Drive, Deep Run Iii Ste. 4000 · Richmond, VA 23233
✎ GovInfoNow plain-language explainer

SEKISUI DIAGNOSTICS' HCG control sets were recalled because thunderstorms caused some to be stored outside recommended cold conditions. This could lead to incorrect or delayed test results if the products are used without proper storage. Read more at govinfonow.com/recall/52385-sekisui-hcg-control-set-recall-cold-storage-issues-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/52385-sekisui-hcg-control-set-recall-cold-storage-issues-may-cause · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1854-2025

Cite this page

“SEKISUI HCG Control Set Recall: Cold Storage Issues May Cause Incorrect Test Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52385-sekisui-hcg-control-set-recall-cold-storage-issues-may-cause. Based on FDA recall #Z-1854-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1854-2025%22&limit=1).

The FDA announced on April 24, 2025, that Mckesson Medical-Surgical Inc. Corporate Office is recalling SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET products due to transit delays from severe thunderstorms. These delays may have caused the products to be stored outside recommended conditions, potentially leading to incorrect or delayed test results.

How to tell if you have it

  • SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET
  • Catalog No. 138
  • GTIN: 742860100093
  • Order No. 45402895
  • UPC 00742860100093

The hazard

Severe thunderstorms caused transit delays for certain cold chain products, which may have resulted in storage outside the recommended labeled conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Context

GovInfoNow's records show Mckesson Medical-Surgical Inc. Corporate Office has 14 other recalls on record since June 2, 2021. Recent similar recalls include a July 30, 2025, Clearview Strep A Exact II Dipstick Respiratory Kit recall for license classification errors and an April 25, 2025, Medroxyprogesterone Acetate Injectable Vial recall for storage issues after shipping delays. Other recent recalls of similar products include a May 28, 2026, Medline Convenience Kits recall for temperature probe distribution errors and an April 23, 2026, Covidien Mon-a-Therm Temperature Probe recall for lack of FDA clearance.

How to tell if you have this one

Check for catalog number 138 on the product label. The product was sold with GTIN 742860100093 and order number 45402895.

  • Brand
    SEKISUI DIAGNOSTICS
  • Product
    SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET
  • Category
    Medical device
FDA recall event · 32 products

All 32 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
    Ongoing
  • Distribution
    US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.
Recall numberProduct, codes & lotsQuantity
Z-1824-2025ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL; Catalog No. 88773; GTIN: 893038002036; Order No. 46108009.1 unit
Z-1825-2025ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.; Catalog No. 97989; GTIN: 893038002913; Order No. 46115470.100 units
Z-1826-2025ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.; Catalog No. 97991; GTIN: 893038002937; Order No. 46102674.50 units
Z-1827-2025HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.; Catalog No. 110706; GTIN: 17311091107067; Order No. 46085136.4 units
Z-1828-2025BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.; Catalog No. 221196; GTIN: 30382902211960; Order No. 44987370.100 units
Z-1829-2025BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.; Catalog No. 221270; GTIN: 10382902212703; Order No. 45723808.200 units
Z-1830-2025ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.; Catalog No. 1116974; GTIN: 7070060014654; Order No. 46085136 & 46115470.8 units
Z-1831-2025ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT.; Catalog No. 1450261; GTIN: 10758750009114; Order No. 46117007.5 units
Z-1832-2025ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.; Catalog No. 1513209; GTIN: 10758750009220; Order No. 46094482.10 units
Z-1833-2025ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.; Catalog No. 6801709; GTIN: 10758750006731; Order No. 46093490.300 units
Z-1834-2025ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.; Catalog No. 6801754; GTIN: 10758750007004; Order No. 46084922.3 units
Z-1835-2025ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.; Catalog No. 6844296; GTIN: 10758750031801; Order No. 46033333.600 units
Z-1836-2025ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.; Catalog No. 6901935; GTIN: 10758750007448; Order No. 46044105.1 unit
Z-1837-2025ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.; Catalog No. 8102204; GTIN: 10758750004362; Order No. 46047530.60 units
Z-1838-2025HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.; Catalog No. 171001002; GTIN: 8718734960300; Order No. 46085136.1 unit
Z-1839-2025HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.; Catalog No. 171003002; GTIN: 8718734960348; Order No. 46085136.1 unit
Z-1840-2025ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.; Catalog No. 01E6403; GTIN: 380740161378; Order No. 46043577.1 unit
Z-1841-2025ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.; Catalog No. 01L5640; GTIN: 380740001193; Order No. 46048552.1 unit
Z-1842-2025ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.; Catalog No. 01L8227; GTIN: 380740115364; Order No. 46061983.4 units
Z-1843-2025ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.; Catalog No. 02K4727; GTIN: 380740048327; Order No. 46048552.1 unit
Z-1844-2025ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.; Catalog No. 02K4825; GTIN: 380740003517; Order No. 46061983.2 units
Z-1845-2025ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.; Catalog No. 02P3601; GTIN: 380740003876; Order No. 46061983.1 unit
Z-1846-2025ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.; Catalog No. 03P8425; GTIN: 10054749000125; Order No. 46085650.25 units
Z-1847-2025ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.; Catalog No. 04P5325; GTIN: 380740007775; Order No. 46061983.400 units
Z-1848-2025ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.; Catalog No. 05P0202; GTIN: 380740142742; Order No. 46048552.1 unit
Z-1849-2025ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.; Catalog No. 07K6402; GTIN: 380740144845; Order No. 46061983.1 unit
Z-1850-2025ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.; Catalog No. 07K6502; GTIN: 380740081034; Order No. 46048552.1 unit
Z-1851-2025ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.; Catalog No. 07K7725; GTIN: 380740014919; Order No. 46048552.1 unit
Z-1852-2025ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.; Catalog No. 07P9321; GTIN: 380740158330; Order No. 46052126.2 units
Z-1853-2025ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.; Catalog No. 09P2720; GTIN: 380740151362; Order No. 46050138.1 unit
Z-1854-2025SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.; Catalog No. 138; GTIN: 742860100093; Order No. 45402895.1 unit
Z-1855-2025HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.; Catalog No. 180.013.002; GTIN: 8718734960935; Order No. 46096008.1 unit
Based on the official FDA remedy

What to do — step by step

  1. Check Storage Conditions

    Ensure the control set is stored at the recommended cold temperature if you have it.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arkansas, Illinois, Kansas, Montana, New Jersey, North Carolina, Oregon, South Carolina, Tennessee, West Virginia.

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Apr 24, 202512. FDA classified it Class II: May 27, 202523. Published in FDA’s Enforcement Report: Jun 4, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1854-2025 (April 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1854-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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