Recall Z-0739-2023— Abbott Molecular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Abbott Molecular, Inc., initiated 2022-11-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096. Reason: Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits..
- Recalling firm
- Abbott Molecular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-22
- Firm location
- Des Plaines, IL, United States
Product description
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reason for recall
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.