Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- November 22, 2022
- Posted
- December 20, 2022
- Recall Number
- Z-0739-2023
- Quantity
- 3896 kits
- Firm Location
- Des Plaines, IL
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.
Distribution
Worldwide
Lot / Code Info
Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499
Root Cause
Under Investigation by firm
Action Taken
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 with laboratory personnel and retain this communication for future reference. If you have any questions regarding this communication, please contact your local Abbott representative, or call Abbott Technical Support at 1-800-55-7042 Option 2."