Z-1748-2025Class II

Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse...

Name: Z-1748-2025 Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse...
Creator: Abbott Molecular, Inc.
Published: 2025-04-28
License: https://open.fda.gov/license/

Abbott Molecular, Inc. / initiated 2025-04-28 / Open, Classified

FDA source

Abbott Molecular, Inc. began a recall of Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR)... on 2025-04-28. FDA classified it as Class II and gives the reason as "There were reports of an increase in reactive negative controls and false positive results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1748-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-28
Posted: 2025-05-12
Recalling firm: Abbott Molecular, Inc.
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
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: There were reports of an increase in reactive negative controls and false positive results.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1447 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1748-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1748-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-12
Z-1749-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-12

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)