Alinity m Resp-4-Plex Kit (Abbott) – Test Result Anomalies (2025)
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
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection
Brand
Abbott Molecular, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00884999049338, Lot Numbers: 409383 410627 411921
Products Sold
UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921
Abbott Molecular, Inc. is recalling Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time rev due to There were reports of an increase in reactive negative controls and false positive results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There were reports of an increase in reactive negative controls and false positive results.
Recommended Action
Per FDA guidance
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.
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