Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Brand
Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany
Lot Codes / Batch Numbers
a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00, b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00
Products Sold
a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00
Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany is recalling ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 due to Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Abbott issued an Urgent Product Correction notice to its consignees on 03/04/2024 via FedEx. The notice explained the issue, impact on patient results, and requestee the following: Installation of the most current assay file version(s) of the assay(s) used by your laboratory. The new assay file(s) may be requested from Abbott Mail for systems connected to AbbottLink. Alternatively, for systems not connected to AbbottLink, the revised assay file may be downloaded from www.corelaboratory.abbott. Installation of the new assay file version will require new calibration as per ARCHITECT System / Alinity ci series Operations Manual. Therefore, please deplete your current on board ARCHITECT Anti-HCV, ARCHITECT AdviseDx SARS-CoV-2-IgG II and Alinity i Anti-HCV reagent kits before installing the new assay file versions and perform a manual backup. For additional support for the new assay file installations, please contact your customer service representative. " Previously reported Alinity i Anti-HCV, ARCHITECT Anti-HCV test results may be reviewed with the Medical Director or Laboratory Management per the laboratory protocol. " For diagnostic purposes, Alinity i Anti-HCV, ARCHITECT Anti-HCV results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic hepatitis C infection. " If you have forwarded the Alinity i Anti-HCV, ARCHITECT Anti-HCV and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II product to other laboratories, please inform them of this Product Correction and provide them a copy of this letter. " Complete and return the Customer Reply Form. " Please retain this letter for your laboratory records. For questions regarding this information, please contact Customer Service at 1-877-4 ABBOTT (available 24 hours a day, 7 days a week).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026