FDA-Device2022-03-23Class II
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Bio-Rad Laboratories, Inc.
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
Sold states
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.
Affected count
724 Calibrator sets (U.S.)
Manufactured in
6565 185th Ave Ne, N/A, Redmond, WA, United States
Products
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2022Don't want to check this manually?
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