Official recall record
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-04-24
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10054749000125
- Brand on record
- Mckesson Medical-Surgical Inc. Corporate Office
- Product category
- Medical Device
What the authority reported
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-04-24 · US FDA — Medical Devices
ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT. - 2025-04-24 · US FDA — Medical Devices
ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT. - 2025-04-24 · US FDA — Medical Devices
SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
All 18 official recall notices naming Mckesson Medical-Surgical Inc. Corporate Office on this site →
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