Abbott recalls ARCHITECT HAVAB G Reagent Kit (List 6L27 25) due to potential decreased hepatitis A virus antigen. Affected lots may produce inaccurate test results. Consumers should contact Abbott for details.
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Abbott is recalling ARCHITECT HAVAB G Reagent Kits that may have been manufactured with an incorrect hepatitis A virus concentration, leading to less antigen than intended. This could cause test results to be inaccurate, potentially affecting diagnosis and treatment decisions.
The reagent kits were manufactured with an erroneous concentration of hepatitis A virus antigen, resulting in less antigen than intended. This could lead to test results being inaccurate, potentially causing incorrect diagnoses or treatment decisions.
People using the ARCHITECT HAVAB G Reagent Kit for hepatitis A testing may be affected. Those who have used the recalled lots for testing are most at risk of inaccurate results.
Check the lot numbers: 03429BE00, 06172BE00, 08073BE00, or 10353BE00. The UDI codes include specific sequences matching these lot numbers.
Look for lot numbers 03429BE00, 06172BE00, 08073BE00, or 10353BE00 on the reagent kit packaging.
Reach out to Abbott directly for specific instructions on whether your kit is affected and what to do next.
Abbott recalls these kits because they were manufactured with an erroneous concentration of hepatitis A virus antigen, which could lead to less antigen than intended and inaccurate test results.
The affected lot numbers are 03429BE00, 06172BE00, 08073BE00, and 10353BE00.
The recall does not require immediate discontinuation; contact Abbott to determine if your kit is affected and follow their instructions.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1728-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1728-2020 from Abbott. 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.