Device product
BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Z-0807-2022
Product summary
- 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
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