FDA Medical Device Recalls (openFDA)
Abbott Molecular, Inc.: Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
- Recall number
- Z-0740-2023
- Recalling firm
- Abbott Molecular, Inc.
- Product
- Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
- Status
- Open, Classified
- Initiated
- 2022-11-22
- Posted
- 2022-12-20
- Terminated
- not on file
- 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 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."
- Quantity
- 12116 kits
- Distribution
- Worldwide
- Lot, serial or model codes
- Lot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 3005248192
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28