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Recall Observatory FDA recall evidence

Device product

BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack

Z-1096-2022

April 14, 2022

Class II

Product summary

Firm
Bio-Rad Laboratories, Inc.
Event
Event 90026
Status
Ongoing
Classification
Class II
Quantity
348 units
Official record key
device-enforcement:Z-1096-2022

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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