Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

FDA device recall Z-0739-2023 · posted 2022-12-20 · Open, Classified

Recall details

Recalling firm

Abbott Molecular, Inc.

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.

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."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QJR

Quantity affected

3896 kits

Distribution

Worldwide

Date initiated

2022-11-22

Date posted

2022-12-20

Location

Des Plaines, IL