Recall Z-1480-2024 ยท MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Abbott GmbH
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
| Date | Apr 4, 2024 (initiated Mar 4, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 5110 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.