FDA-Device2023-05-17Class II
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Bio-Rad Laboratories, Inc.
Hazard
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Sold states
US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.
Affected count
932 Reagent Packs
Manufactured in
6565 185th Ave Ne, N/A, Redmond, WA, United States
Products
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1572-2023Don't want to check this manually?
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