Drug recall
Alinity i Anti-HCV Reagent Kit, List Number 08P0521
FDA recall event 94205 · Class II · Abbott GmbH
Key facts
| Event ID | 94205 |
|---|---|
| Recall numbers | Z-1479-2024, Z-1480-2024 |
| Recalling firm | Abbott GmbH |
| Product type | Devices |
| Products | Alinity i Anti-HCV Reagent Kit, List Number 08P0521, ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 4, 2024 |
| Report date | Apr 10, 2024 |
| City | Wiesbaden |
| Country | Germany |
| FEI number | 3002809144 |
At a glance
- 1–9 Products in this recall
- 1–9 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: