Device recall
Z-0004-2022: Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity…
FDA device recall · Class I · Abbott Molecular, Inc.
Key facts
| Recall number (Z-number) | Z-0004-2022 |
|---|---|
| Recall event | 88626 |
| Product | Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic |
| Product code | QJR |
| Recalling firm | Abbott Molecular, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 23, 2024 |
| 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