Class 2 Device Recall Alinity i AntiHCV Reagent Kit

• Date Initiated by Firm: March 04, 2024
• Date Posted: April 04, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1480-2024
• Recall Event ID: 94205
• PMA Number: P050042
• Product Classification: Assay, enzyme linked immunosorbent, hepatitis c virus - Product Code MZO
• Product: Alinity i Anti-HCV Reagent Kit, List Number 08P0521
• Code Information: UDI/DI 00380740130657, Lot Numbers: 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00
• Recalling Firm/ Manufacturer: Abbott GmbH; Max-Planck-Ring 2; Wiesbaden Germany
• For Additional Information Contact: Suchin Song; 224-668-0343
• Manufacturer 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).
• FDA Determined 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: 5110 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MZO