bioMerieux, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0742-2022)

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 CMV IgM, 30 tests, REF 30205-01, IVD, Rx.

Product Classification:

Class II

Date Initiated: February 9, 2022

Date Posted: October 5, 2022

Recall Number: Z-0742-2022

Event ID: 89568

Reason for Recall:

Invalid calibrations (out of range high) while using the product.

Status: Completed

Product Quantity: 480 kits

Code Information:

Lot numbers 1008873260, exp. 01JUN2022.

Distribution Pattern:

Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated