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Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Recalled March 23, 2022 · FDA recall Z-0806-2022 · Bio-Rad Laboratories
Hazard
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications · FDA Class II
Units
9,426 packs (U.S.)
Sold at
Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Saudi Arabia, and United Arab Emirates.
Description
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
Product
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Manufacturer(s)
Bio-Rad Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →