Abbott Diagnostics Anti-HBS Reagent Recall Due to Storage Temperature Failure
Abbott Diagnostics ARCH AUSAB ANTI-HBS reagent is being recalled due to cold chain storage failures caused by transit delays. Exposure to temperatures outside labeled requirements may increase the risk of incorrect or delayed test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or confirmed test result failures. The hazard involves increased probability of inaccurate or delayed test results from temperature excursion, representing potential risk to patient safety from diagnostic errors, but actual harm has not been reported.
Plain-English summary
Abbott Diagnostics ARCH AUSAB ANTI-HBS (100/EA) reagent is being recalled by manufacturer McKesson Medical-Surgical Inc. due to cold chain storage failures during transit.
Severe thunderstorms caused transit delays that exposed the product to temperatures outside its recommended labeled storage conditions. This temperature excursion may compromise product integrity and increase the risk of incorrect or delayed test results.
The recalled product was distributed nationwide to Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Healthcare providers and customers should discontinue use of affected product and contact their supplier for replacement units. As of the recall announcement, no illnesses or injuries related to this product have been reported.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- inaccurate-test-results
- delayed-test-results
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. 01L8227
- GTIN: 380740115364
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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