Abbott Molecular, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1749-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 28, 2025

Date Posted: May 21, 2025

Recall Number: Z-1749-2025

Event ID: 96790

Reason for Recall:

There were reports of an increase in reactive negative controls and false positive results.

Status: Ongoing

Product Quantity: 656 units

Code Information:

UDI-DI: 00884929049390; Lot Number: 409384

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated