Abbott ARCHITECT HBSAG Assay Reagent Recall Due to Storage Condition Failure
Abbott ARCHITECT HBSAG Assay reagent may have been stored outside recommended conditions due to transit delays caused by severe thunderstorms, potentially resulting in 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 involving a diagnostic reagent where storage-condition excursions may result in test inaccuracy. No illnesses or injuries have been reported; the hazard is potential functional failure rather than direct patient harm. The recall is precautionary in nature, consistent with a Moderate severity rating.
Plain-English summary
Abbott Diagnostics ARCHITECT HBSAG Assay (100 test per box) BDS Reagent is being recalled due to transit delays caused by severe thunderstorms. These delays may have resulted in the products being stored outside the manufacturer's recommended labeled storage conditions.
This failure to maintain proper storage conditions could increase the probability of an incorrect test result or a delayed test result. The product is distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Healthcare facilities and laboratories that have received this product should review their records and consider testing the affected reagent batches before continuing use. Catalog Number 04P5325 (GTIN 380740007775, Order Number 46061983) is affected in quantities of 400 units.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 400
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. 04P5325
- GTIN: 380740007775
- Order No. 46061983.
Distribution
Part of a larger recall action
This product is one of 32 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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