Recall Z-0004-2022— Abbott Molecular, Inc.
Class I · Terminated
Class I FDA medical device recall by Abbott Molecular, Inc., initiated 2021-09-02, terminated 2024-07-23. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: There is a potential for false positive results..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-09-02
- Terminated
- 2024-07-23
- Firm location
- Des Plaines, IL, United States
Product description
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Reason for recall
There is a potential for false positive results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.