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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Abbott, BD, and Ortho Diagnostic Tests Recalled for Temperature Issues

Agency Publication Date: May 27, 2025
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Summary

McKesson Medical-Surgical Inc. is recalling 1,888 units of various cold-chain diagnostic tests, reagents, and control kits across multiple brands including Abbott, BD, HemoCue, and Ortho Clinical Diagnostics. These products were exposed to temperatures outside of their recommended labeled storage conditions due to shipping delays caused by severe thunderstorms. This exposure could potentially degrade the products, leading to incorrect or delayed medical test results.

Risk

Using reagents or tests that have been stored outside of specified temperature ranges can cause chemical instability, leading to inaccurate diagnostic data. An incorrect test result could result in a patient receiving improper medical treatment or experiencing a delay in the diagnosis of a serious condition.

What You Should Do

  1. This recall affects various laboratory diagnostic products including Cholestech cassettes, microbiology media, clinical reagents, and control solutions sold under the Abbott, BD, HemoCue, Ortho Clinical Diagnostics, and Sekisui brands. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled diagnostic products immediately and quarantine any remaining stock to prevent further use.
  3. Contact McKesson Medical-Surgical Inc. or your laboratory equipment distributor to arrange for the return, replacement, or correction of the affected materials.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Abbott Rapid DX Multi Analyte Lvl1 & 2 250UL Chols Control
Model / REF:
88773
GTIN:
893038002036

Recall #: Z-1824-2025; Order No. 46108009

Product: Abbott Rapid DX Test Cholestech LDX Lipid Profile (10/BX 50BX/CS) Cassettes
Model / REF:
97989
GTIN:
893038002913

Recall #: Z-1825-2025; Order No. 46115470

Product: Abbott Rapid DX Cholestech LDX Lipid Profile+Glucose (10/BX 50BX/CS) Test
Model / REF:
97991
GTIN:
893038002937

Recall #: Z-1826-2025; Order No. 46102674

Product: HemoCue Inc F/Glucose 201 Analyzer (25/VL 4VL/BX) Microcuvette
Model / REF:
110706
GTIN:
17311091107067

Recall #: Z-1827-2025; Order No. 46085136

Product: BD Microbiology Fluid Thioglycollate Med Tube 1004321196 (100/CT) Media
Model / REF:
221196
GTIN:
30382902211960

Recall #: Z-1828-2025; Order No. 44987370

Product: BD Microbiology Mac Conkey II Agar (100/CT) 21270 Media
Model / REF:
221270
GTIN:
10382902212703

Recall #: Z-1829-2025; Order No. 45723808

Product: Abbott Rapid DX HbA1c Hemoglobin Afinion Glyctd (15TST/BX) Test Kit
Model / REF:
1116974
GTIN:
7070060014654

Recall #: Z-1830-2025; Order No. 46085136 & 46115470

Product: Ortho Clinical Diagnostics Vitros Calcium (L-Sequester) (300/PK) Reagent
Model / REF:
1450261
GTIN:
10758750009114

Recall #: Z-1831-2025; Order No. 46117007

Product: Ortho Clinical Diagnostics Vitros Phosphorus (60/CR 5CR/PK) Reagent
Model / REF:
1513209
GTIN:
10758750009220

Recall #: Z-1832-2025; Order No. 46094482

Product: Ortho Clinical Diagnostics Vancomycin (300/BX) Reagent
Model / REF:
6801709
GTIN:
10758750006731

Recall #: Z-1833-2025; Order No. 46093490

Product: Ortho Clinical Diagnostics FS(3PK/BX) Diluent Pack 3
Model / REF:
6801754
GTIN:
10758750007004

Recall #: Z-1834-2025; Order No. 46084922

Product: Ortho Clinical Diagnostics Total Bili-ALKP XT (L-Sequester) (300/PK) Reagent
Model / REF:
6844296
GTIN:
10758750031801

Recall #: Z-1835-2025; Order No. 46033333

Product: Ortho Clinical Diagnostics Anti-B Bioclone 10ml 3X10ml
Model / REF:
6901935
GTIN:
10758750007448

Recall #: Z-1836-2025; Order No. 46044105

Product: Ortho Clinical Diagnostics Vitros BUN (60/CR 5CR/PK) Reagent
Model / REF:
8102204
GTIN:
10758750004362

Recall #: Z-1837-2025; Order No. 46047530

Product: HemoCue Inc Hemotrol Low 2X1ml Level 1 Control
Model / REF:
171001002
GTIN:
8718734960300

Recall #: Z-1838-2025; Order No. 46085136

Product: HemoCue Inc Hemotrol High 2X1ml Level 3 Control
Model / REF:
171003002
GTIN:
8718734960348

Recall #: Z-1839-2025; Order No. 46085136

Product: Abbott Diagnostics ARC Carbon Dioxide 6X5ml B Calibrator
Model / REF:
01E6403
GTIN:
380740161378

Recall #: Z-1840-2025; Order No. 46043577

Product: Abbott Diagnostics Probe Conditioning F/Architect Analyz Solution
Model / REF:
01L5640
GTIN:
380740001193

Recall #: Z-1841-2025; Order No. 46048552

Product: Abbott Diagnostics Arch Ausab Anti-HBs (100/EA) Reagent
Model / REF:
01L8227
GTIN:
380740115364

Recall #: Z-1842-2025; Order No. 46061983

Product: Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent
Model / REF:
02K4727
GTIN:
380740048327

Recall #: Z-1843-2025; Order No. 46048552

Product: Abbott Diagnostics ARC T-Uptake Assay (100TST/BX) Reagent
Model / REF:
02K4825
GTIN:
380740003517

Recall #: Z-1844-2025; Order No. 46061983

Product: Abbott Diagnostics Architect HIV Combo 1X4ml Calibrator
Model / REF:
02P3601
GTIN:
380740003876

Recall #: Z-1845-2025; Order No. 46061983

Product: Abbott Point of Care Test Crea i-STAT (25/BX) Cartridge
Model / REF:
03P8425
GTIN:
10054749000125

Recall #: Z-1846-2025; Order No. 46085650

Product: Abbott Diagnostics Architect HBsAg Assay (100TST/BX) Reagent
Model / REF:
04P5325
GTIN:
380740007775

Recall #: Z-1847-2025; Order No. 46061983

Product: Abbott Diagnostics Architect Vitamin D 6-Level Calibrator
Model / REF:
05P0202
GTIN:
380740142742

Recall #: Z-1848-2025; Order No. 46048552

Product: Abbott Diagnostics Architect Total T3 6X4ml Calibrator
Model / REF:
07K6402
GTIN:
380740144845

Recall #: Z-1849-2025; Order No. 46061983

Product: Abbott Diagnostics Architect Free T4 Calibrator
Model / REF:
07K6502
GTIN:
380740081034

Recall #: Z-1850-2025; Order No. 46048552

Product: Abbott Diagnostics Architect Progesterone (100 Tests) Reagent
Model / REF:
07K7725
GTIN:
380740014919

Recall #: Z-1851-2025; Order No. 46048552

Product: Abbott Diagnostics Alinity i Free PSA US (200 Test/EA) Reagent
Model / REF:
07P9321
GTIN:
380740158330

Recall #: Z-1852-2025; Order No. 46052126

Product: Abbott Diagnostics Alinity i Anti-CCPS Reagent
Model / REF:
09P2720
GTIN:
380740151362

Recall #: Z-1853-2025; Order No. 46050138

Product: Sekisui Diagnostics LLC Serum hCG Osomgenzme Control Set
Model / REF:
138
GTIN:
742860100093

Recall #: Z-1854-2025; Order No. 45402895

Product: HemoCue Inc Gluc Aqueous 1 Hi/Lo Control Kit
Model / REF:
180.013.002
GTIN:
8718734960935

Recall #: Z-1855-2025; Order No. 46096008

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96752
Status: Active
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Sold By: McKesson Medical-Surgical Inc.
Manufactured In: United States
Units Affected: 32 products (1 unit; 100 units; 50 units; 4 units; 100 units; 200 units; 8 units; 5 units; 10 units; 300 units; 3 units; 600 units; 1 unit; 60 units; 1 unit; 1 unit; 1 unit; 1 unit; 4 units; 1 unit; 2 units; 1 unit; 25 units; 400 units; 1 unit; 1 unit; 1 unit; 1 unit; 2 units; 1 unit; 1 unit; 1 unit)
Distributed To: Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.