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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Alinity m Resp4Plex Amp Kit

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  Class 2 Device Recall Abbott Alinity m Resp4Plex Amp Kit see related information
Date Initiated by Firm November 22, 2022
Date Posted December 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0740-2023
Recall Event ID 91202
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
Product Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Code Information Lot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;
Recalling Firm/
Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information Contact Ray Bastian
Manufacturer 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 Determined
Cause 2
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 12116 kits
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.