Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure
Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing 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. The source text explicitly states only the theoretical risk of incorrect or delayed results with no reported illnesses or injuries, making it a precautionary action consistent with the Moderate severity level.
Plain-English summary
Abbott HbA1c Hemoglobin Afinion test kits (Catalog No. 1116974, GTIN 7070060014654) are being recalled by McKesson Medical-Surgical Inc. due to storage condition failures during shipment. Severe thunderstorms caused transit delays for certain cold chain products, which may have resulted in the test kits being stored outside the manufacturer's labeled storage conditions.
This failure could increase the probability of an incorrect test result or a delayed test result. The recalled product was distributed nationwide to facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Eight units were affected.
Patients and healthcare providers in affected states using these test kits should contact McKesson Medical-Surgical Inc. or consult with their healthcare provider regarding the reliability of test results obtained from potentially affected kits.
The recalled product
- Product
- ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-condition-failure
- inaccurate-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. 1116974
- GTIN: 7070060014654
- Order No. 46085136 & 46115470.
Distribution
Distributed nationwide across the United States.
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