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Recall Observatory FDA recall evidence

Device product

BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Z-0807-2022

February 08, 2022

Class II

Product summary

Firm
Bio-Rad Laboratories, Inc.
Event
Event 89684
Status
Ongoing
Classification
Class II
Quantity
724 Calibrator sets (U.S.)
Official record key
device-enforcement:Z-0807-2022

Official wording

Reason: 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

Code information: Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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