Abbott recalls Alinity i Anti-HCV Reagent Kit (List 08P0521) due to potential false elevated results when used with specific syphilis and SARS-CoV-2 tests. Affected units include certain lot numbers.
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
Abbott is recalling Alinity i Anti-HCV Reagent Kit (List Number 08P0521) because it can cause false elevated results when used with certain other tests. This could lead to incorrect diagnoses of hepatitis C if the kit is used improperly with specific syphilis and SARS-CoV-2 tests.
The kit can produce false elevated results when used with specific syphilis and SARS-CoV-2 tests on the same instrument. This happens when the syphilis or SARS-CoV-2 tests are run first, followed by the hepatitis C test. The false results could lead to incorrect diagnoses.
People who use the Alinity i Anti-HCV Reagent Kit for hepatitis C testing, especially those who run the kit after syphilis or SARS-CoV-2 tests on the same instrument. Laboratory staff and healthcare providers are most at risk.
Check for the product name 'Alinity i Anti-HCV Reagent Kit' with List Number 08P0521. Look for lot numbers 52020BE00, 54149BE00, 56384BE00, 58172BE00, or 59203BE00.
Verify the product name, list number, and lot numbers to confirm if your kit is affected.
The kit can cause false elevated results when used with specific syphilis and SARS-CoV-2 tests on the same instrument, leading to incorrect hepatitis C diagnoses.
Lot numbers 52020BE00, 54149BE00, 56384BE00, 58172BE00, and 59203BE00.
No action is required for the kit itself, but ensure it is not used with specific syphilis or SARS-CoV-2 tests on the same instrument.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1480-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1480-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
