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Bio-Rad Laboratories, Inc. Recall 89684

Description: BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Bio-Rad Laboratories, Inc. Recall 89684 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0807-2022
Event ID89684
Event DescriptionBioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Product TypeDevices
DistributionWorldwide 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.
Quantity724 Calibrator sets (U.S.)
Recall ReasonDue 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
Device Classification20220323
Device Code InfoCatalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262
Center Classification Date20220316
Recall Initiation Date20220208
Recalling FirmBio-Rad Laboratories, Inc.
Initial Notification Letter
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