FDA-Device2022-05-25Class II
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Bio-Rad Laboratories, Inc.
Hazard
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Sold states
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.
Affected count
348 units
Manufactured in
6565 185th Ave Ne, N/A, Redmond, WA, United States
Products
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1096-2022Don't want to check this manually?
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