FDA Medical Device Recalls (openFDA)
Abbott GmbH: ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
- Recall number
- Z-1479-2024
- Recalling firm
- Abbott GmbH
- Product
- ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
- Status
- Open, Classified
- Initiated
- 2024-03-04
- Posted
- 2024-04-04
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Device Design
- Action
- 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).
- Quantity
- 7219 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00
- 510(k) numbers
- not on file
- PMA numbers
- ["P050042"]
- Product code
- MZO
- Firm FEI
- 3002809144
- Firm city
- Wiesbaden
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28