Z-0807-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 23, 2022
- Initiation Date
- February 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 724 Calibrator sets (U.S.)
Product Description
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Reason for Recall
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
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.
Code Information
Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262