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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity m Resp4Plex AMP Kit

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 Class 2 Device Recall Alinity m Resp4Plex AMP Kitsee related information
Date Initiated by FirmApril 28, 2025
Date PostedMay 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1749-2025
Recall Event ID 96790
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
ProductAlinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.
Code Information UDI-DI: 00884929049390; Lot Number: 409384
Recalling Firm/
Manufacturer		 Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines IL 60018-3315
For Additional Information ContactPamela Yip
224-416-3014
Manufacturer Reason
for Recall		There were reports of an increase in reactive negative controls and false positive results.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn Urgent Field Safety Notice/ Field Correction Recall notification letter dated 4/24/25 was sent to customers. Necessary Actions: " Discard inventory of the lot listed in the above table. Contact Abbott Customer Support for replacement of any unused kit(s). " If you have forwarded any kits of this lot 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 1-800-553-7042 Option 2. We apologize for any inconvenience this may have caused your laboratory.
Quantity in Commerce656 units
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC 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.
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