Alinity 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.
- Company
- Abbott Molecular, Inc.
- Recall Initiated
- April 28, 2025
- Posted
- May 12, 2025
- Recall Number
- Z-1749-2025
- Quantity
- 656 units
- Firm Location
- Des Plaines, IL
Reason for Recall
There were reports of an increase in reactive negative controls and false positive results.
Distribution
Worldwide - US Nationwide distribution.
Lot / Code Info
UDI-DI: 00884929049390; Lot Number: 409384
Root Cause
Under Investigation by firm
Action Taken
An 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.