Abbott Molecular, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0740-2023)

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 09N79-090

Product Classification:

Class II

Date Initiated: November 22, 2022

Date Posted: December 28, 2022

Recall Number: Z-0740-2023

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: 12116 kits

Code Information:

Lot Numbers: 381177, exp 8/24/2023; 525460, exp ; 525766, exp ; 526393, exp ; 526483, exp ; 527142, exp ; 527403, exp ; 527602, exp ; 531612, exp ;

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated