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Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Recalled May 25, 2022 · FDA recall Z-1096-2022 · Bio-Rad Laboratories
Hazard
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack. · FDA Class II
Units
348 units
Sold at
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.
Description
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Product
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Manufacturer(s)
Bio-Rad Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →