Z-1479-2024Class II

ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

Name: Z-1479-2024 ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Creator: Abbott GmbH
Published: 2024-03-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-03-04 / Open, Classified / root cause: design

FDA source

Abbott GmbH began a recall of ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 on 2024-03-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1479-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-04
Posted: 2024-04-04
Recalling firm: Abbott Medical
Product: ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Product code: MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Reason for recall: 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 tag: design
FDA 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 in commerce: 7219 units
Distribution: US Nationwide distribution.
Product codes and lots: a) 1L79-25, 00380740001414, Lot Numbers: 52011BE00, 54140BE00, 56375BE00, 58163BE00, 59194BE00; b) 1L79-35, 00380740001421, Lot Numbers: 52015BE00, 54144BE00, 56379BE00, 58167BE00, 59198BE00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1479-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1479-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-04
Z-1480-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-04

Product code MZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)