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Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Recalled May 17, 2023 · FDA recall Z-1572-2023 · Bio-Rad Laboratories
Hazard
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results. · FDA Class II
Units
932 Reagent Packs
Sold at
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.
Description
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
Product
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Manufacturer(s)
Bio-Rad Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →