Recall Z-0739-2023 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Abbott Molecular, Inc.
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
| Date | Dec 20, 2022 (initiated Nov 22, 2022) |
| Status | Open, Classified |
| Reason | Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. |
| Root cause | Under Investigation by firm |
| Action | Abbott Molecular issue an Urgent Field Safety Notice /Field Correction Recall to its consignees on 11/22/2022 by FedEx priority express. The notice explained the issue and requested the following actions: "- Discard inventory of any lots listed in Appendix A below. Contact Abbott Customer Support for credit of any unused kit(s). - If you have forwarded any kits of these lots to other laboratories, please inform them of this Urgent Field Safety Notice /Field Correction Recall, and provide a copy of this letter. - Return the associated Customer Reply form. Please review this information wit |
| Quantity | 3896 kits |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.