Abbott Molecular, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1748-2025)

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 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 Classification:

Class II

Date Initiated: April 28, 2025

Date Posted: May 21, 2025

Recall Number: Z-1748-2025

Event ID: 96790

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1447 units

Code Information:

UDI-DI: 00884999049338; Lot Numbers: 409383 410627 411921

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated