Abbott Diagnostics ARCH AUSAB Anti-HBS Reagent Recall
Abbott Diagnostics ARCH AUSAB Anti-HBS reagent units may have been stored outside recommended temperature conditions due to transit delays caused by severe thunderstorms, potentially leading to 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 with no reported illnesses or injuries. The hazard is a potential for incorrect or delayed test results due to storage condition excursions, which is a precautionary concern without evidence of actual harm occurring.
Plain-English summary
Abbott Diagnostics ARCH AUSAB Anti-HBS (100/EA) Reagent distributed in the United States is being recalled. The affected product is Catalog No. 01L8227 with GTIN 380740115364.
Certain units of this cold chain product experienced transit delays due to severe thunderstorms, which may have 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.
The product was distributed nationwide in the states of Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Consumers and healthcare providers who have received this product should contact the recalling firm, Mckesson Medical-Surgical Inc. Corporate Office, for guidance on proper handling or return of affected units.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-temperature-excursion
- test-result-accuracy
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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