Abbott recalls specific ARCHITECT Anti-HCV Reagent Kits (list numbers 1L79-25 and 1L79-35) due to potential false elevated results when used with certain other tests on the same instrument.
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 two specific reagent kits for HCV testing because they can cause false high results when used with certain other tests on the same machine. This could lead to incorrect diagnoses if the tests are run in the wrong order.
The reagent kits can produce false elevated results when certain other Abbott tests (like Syphilis TP or SARS-CoV-2 IgG) are run first on the same instrument. This happens because of interactions between the tests.
Hospitals and labs using the recalled ARCHITECT Anti-HCV Reagent Kits (list numbers 1L79-25 and 1L79-35) may be affected. Those running tests in the wrong sequence with other Abbott tests are most at risk.
Check for list numbers 1L79-25 or 1L79-35. The kits were sold with specific lot numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00 for 1L79-25 and 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00 for 1L79-35.
Ensure that ARCHITECT Syphilis TP or ARCHITECT AdviseDx SARS-CoV-2-IgG II tests are not run before the Anti-HCV test on the same instrument.
Confirm the list numbers of the reagent kits are 1L79-25 or 1L79-35 to identify affected units.
The recall is due to potential false elevated results when certain other Abbott tests are run before the Anti-HCV test on the same instrument.
For list number 1L79-25: lot numbers 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00. For list number 1L79-35: lot numbers 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00.
Check the list number on the kit: 1L79-25 or 1L79-35, and verify the lot numbers listed above.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1479-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1479-2024 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.
