Bio-Rad Laboratories, Inc. Recall 89684
Description: BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Bio-Rad Laboratories, Inc. Recall 89684 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0807-2022 |
| Event ID | 89684 |
| Event Description | BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 724 Calibrator sets (U.S.) |
| Recall 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 |
| Device Classification | 20220323 |
| Device Code Info | Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262 |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20220208 |
| Recalling Firm | Bio-Rad Laboratories, Inc. |
| Initial Notification | Letter |
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