Z-0807-2022 Class II Ongoing
FDA device recall Z-0807-2022 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: 724 Calibrator sets (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
- 724 Calibrator sets (U.S.)
Product Description
Reason for Recall
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.