Drug recall
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in…
FDA recall event 93230 · Class II · Abbott Molecular, Inc.
Key facts
| Event ID | 93230 |
|---|---|
| Recall numbers | Z-0407-2024 |
| Recalling firm | Abbott Molecular, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Oct 30, 2023 |
| Report date | Dec 6, 2023 |
| City | Des Plaines |
| State | IL |
| Country | United States |
| FEI number | 3005248192 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: