Recall Z-0407-2024 ยท MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Abbott Molecular, Inc.
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.
| Date | Nov 29, 2023 (initiated Oct 30, 2023) |
| Status | Open, Classified |
| Reason | Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. |
| Root cause | Other |
| Action | Abbott issued an Urgent Field Safety Notice to its consignees on 10/30/2023 via letter delivered using FedEx priority overnight express. The notice explained the problem, the potential impact/risk to patient, and requested the following actions: -discard all affected product -notify all those to which the products were transferred -follow internal laboratory procedures in the case of suspected incorrect results Credit or replacement will be issued for units discarded/destroyed. Abbott expanded the recall and notified consignees on 07/23/2024 via letter. The letter instructed consignees of a |
| Quantity | 1,881 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.