Device recall
Z-0407-2024: Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The…
FDA device recall · Class II · Abbott Molecular, Inc.
Key facts
| Recall number (Z-number) | Z-0407-2024 |
|---|---|
| Recall event | 93230 |
| Product | 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. |
| Product code | MZP |
| Recalling firm | Abbott Molecular, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P190025 |
| FEI number | 3005248192 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database