Z-0739-2023Class II

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

Name: Z-0739-2023 Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Creator: Abbott Molecular, Inc.
Published: 2022-11-22
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2022-11-22 / Open, Classified

FDA source

Abbott Molecular, Inc. began a recall of Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 on 2022-11-22. FDA classified it as Class II and gives the reason as "Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0739-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-22
Posted: 2022-12-20
Recalling firm: Abbott Molecular, Inc.
Product: Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
FDA 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 in commerce: 3896 kits
Distribution: Worldwide
Product codes and lots: Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0739-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0739-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-20
Z-0740-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-28	2022-12-20

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)