Abbott Diagnostics Hepatitis B Test Reagent Affected by Cold Chain Storage Failure
Abbott hepatitis B diagnostic reagent stored outside recommended conditions due to transit delays from severe thunderstorms. Improper storage could result in inaccurate 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: This is a diagnostic reagent where improper cold chain storage could result in incorrect test results, fitting the rubric criteria for risk-of-harm products where injury has not yet been reported. The FDA Class II classification and absence of reported illnesses or hospitalizations support a High rating.
Plain-English summary
Abbott Diagnostics Architect HBSAG Assay reagent (100 tests per box) distributed nationwide is being recalled due to cold chain storage failures during transit caused by severe thunderstorms.
The products were stored outside the manufacturer's recommended labeled storage conditions during shipping. This storage failure increases the risk of inaccurate or delayed test results.
Affected units include Catalog No. 04P5325 and were distributed to healthcare facilities in AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN, and WV.
Healthcare providers and laboratories using this product should review their testing results and consider retesting where appropriate. Anyone with questions should contact their product supplier or the recalling firm.
The recalled product
- Product
- ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- test-result-inaccuracy
- delayed-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. 04P5325
- GTIN: 380740007775
- Order No. 46061983.
Distribution
Distributed nationwide across the United States.
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