Z-0806-2022 Class II Ongoing
FDA device recall Z-0806-2022 was initiated by Bio-Rad Laboratories, Inc. on February 8, 2022 and is designated Class II. 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 re… The recall status is ongoing. Affected quantity: 9,426 packs (U.S.).
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
- 9,426 packs (U.S.)
Product Description
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
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: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336