bioMerieux, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0438-2022)

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:

VIDAS SARS-COV-2 IgM, Ref 423833-01

Product Classification:

Class II

Date Initiated: September 22, 2021

Date Posted: January 5, 2022

Recall Number: Z-0438-2022

Event ID: 88797

Reason for Recall:

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

Status: Ongoing

Product Quantity: One lot

Code Information:

UDI 03573026620738, Lot #: 1008710950

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated