Abbott Molecular, Inc. Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 381465, exp 8/24/2023, 524433, exp 1/5/2023, 526710, exp 1/21/2023, 527845, exp 2/8/20231499
Products Sold
Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499
Abbott Molecular, Inc. is recalling Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 due to Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026