Drug recall
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application…
FDA recall event 88626 · Class I · Abbott Molecular, Inc.
Key facts
| Event ID | 88626 |
|---|---|
| Recall numbers | Z-0004-2022, Z-0005-2022, Z-0006-2022, Z-0007-2022, Z-0008-2022 |
| Recalling firm | Abbott Molecular, Inc. |
| Product type | Devices |
| Products | Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic, Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic, Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic, Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for false positive results. |
| Initiation date | Sep 2, 2021 |
| Report date | Oct 20, 2021 |
| Termination date | Jul 23, 2024 |
| 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: