Abbott Diagnostics HIV Combo Calibrator Affected by Cold Chain Exposure
Abbott Diagnostics ARCHITECT HIV COMBO Calibrator units may have been exposed to improper storage temperatures due to transit delays during severe thunderstorms, potentially affecting test accuracy.
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 involving a diagnostic calibrator exposed to out-of-specification storage conditions. No illnesses or injuries are reported; the hazard is a potential for incorrect test results, which is a theoretical risk without evidence of actual harm. This meets the threshold for Moderate severity.
Plain-English summary
Abbott Diagnostics ARCHITECT HIV COMBO 1X4ML Calibrator (Catalog No. 02P3601; GTIN 380740003876) is being recalled due to cold chain storage failures during transit.
Certain units were exposed to storage conditions outside the manufacturer's recommended temperature range due to severe thunderstorms causing transit delays. This exposure could increase the probability of incorrect or delayed test results.
The recalled product was distributed nationwide to the states of Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The product is manufactured by Mckesson Medical-Surgical Inc. Corporate Office.
Laboratories and healthcare facilities that received affected units should contact the recalling firm or consult product documentation for guidance on product lot verification and appropriate corrective actions.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- test-accuracy-risk
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. 02P3601
- GTIN: 380740003876
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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