Abbott Diagnostics recalls Architect HBSAG Assay reagents due to transit delays during thunderstorms causing improper storage. This may lead to incorrect or delayed test results. Affected units include specific catalog and GTIN numbers.
transit delays of certain cold chain products due to severe thunderstorms which may 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.
Abbott Diagnostics is recalling certain HBSAG assay reagents because thunderstorms caused some to be stored outside recommended conditions. This could lead to incorrect or delayed test results if used.
The reagents were stored outside recommended temperature conditions due to transit delays caused by severe thunderstorms. This improper storage could lead to incorrect test results or delayed test results when used.
Healthcare facilities using the specific Abbott Diagnostics Architect HBSAG Assay reagents with catalog number 04P5325 and GTIN 380740007775 are affected. Laboratory staff and healthcare providers who use these reagents are most at risk.
Check for the catalog number 04P5325 and GTIN 380740007775 on the reagent packaging. The product was sold by Mckesson Medical-Surgical Inc. Corporate Office.
Ensure the reagent has been stored within the recommended temperature conditions before use.
Transit delays during severe thunderstorms caused some reagents to be stored outside recommended temperature conditions, which could lead to incorrect or delayed test results.
The recall does not require immediate action; check storage conditions and ensure proper temperature before use.
Look for the catalog number 04P5325 and GTIN 380740007775 on the packaging.
We’ve drafted a message you can send Abbott Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1847-2025 — Abbott Diagnostics Abbott Diagnostics Hello, I own a Abbott Diagnostics that is covered by recall Z-1847-2025 from Abbott Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
