Abbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure
McKesson Medical-Surgical is recalling Abbott Point of Care Test Creatinine I-STAT cartridges distributed nationwide after transit delays during severe thunderstorms caused improper storage conditions, increasing the risk of incorrect or delayed test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a medical device with no reported illnesses or injuries. The hazard is a potential for incorrect or delayed test results due to storage excursion, which is a precautionary concern without documented adverse outcomes, fitting the Moderate classification.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Abbott Point of Care Test Creatinine I-STAT cartridges (Catalog No. 03P8425, GTIN 10054749000125) due to transit delays caused by severe thunderstorms. The product was stored outside its recommended labeled storage conditions during shipment.
The affected cartridges were distributed nationwide to Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. This storage failure may increase the probability of an incorrect test result or a delayed test result.
Healthcare providers and laboratories using these cartridges should review their inventory and consult McKesson Medical-Surgical and Abbott for guidance on potentially affected units. Contact the recalling firm with questions about specific lot numbers or order information.
The recalled product
- Product
- ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-excursion
- incorrect-test-result
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog No. 03P8425
- GTIN: 10054749000125
- Order No. 46085650.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22