Bio-Rad Laboratories, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1096-2022)

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:

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Product Classification:

Class II

Date Initiated: April 14, 2022

Date Posted: May 25, 2022

Recall Number: Z-1096-2022

Event ID: 90026

Reason for Recall:

Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.

Status: Ongoing

Product Quantity: 348 units

Code Information:

Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.

Voluntary or Mandated:

Voluntary: Firm initiated