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Bio-Rad Laboratories, Inc. Recall 90026

Description: BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Bio-Rad Laboratories, Inc. Recall 90026 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1096-2022
Event ID90026
Event DescriptionBioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Product TypeDevices
DistributionWorldwide 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.
Quantity348 units
Recall ReasonPerformance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Device Classification20220525
Device Code InfoModel/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388
Center Classification Date20220516
Recall Initiation Date20220414
Recalling FirmBio-Rad Laboratories, Inc.
Initial Notification Letter
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