Home / Recalls / Bio-Rad Laboratories, Inc. / Z-1096-2022

Z-1096-2022 Class II Ongoing

Recalled by Bio-Rad Laboratories, Inc. — Redmond, WA

Recall Details

Product Type
Devices
Report Date
May 25, 2022
Initiation Date
April 14, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
348 units

Product Description

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Reason for Recall

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

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.

Code Information

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

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