Abbott Molecular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0739-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Product Classification:

Class II

Date Initiated: November 22, 2022

Date Posted: December 28, 2022

Recall Number: Z-0739-2023

Event ID: 91202

Reason for Recall:

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

Status: Ongoing

Product Quantity: 3896 kits

Code Information:

Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated