Recall Z-0806-2022 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Bio-Rad Laboratories, Inc.
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
| Date | Feb 8, 2022 |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | On 02/08/2022, the firm sent out an "UGENT: Medical Device Correction" letter to customers via overnight FedEx informing them that the Recalling Firm continues to receive reports of false reactive RPR results despite labeling revisions and the previous Technical Bulleting dated December 2021 (LB003034revA). This is in response to ongoing concerns related to COVID-19 vaccine interference with RPR and the stability issue that led to the short dating of lot, the Recalling Firm is taking the additional field action to disable the RPR portion of the Syphilis Total and RPR panels until further noti |
| Quantity | 9,426 packs (U.S.) |
| 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, Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR C Bio-Rad Laboratories, May 11, 2017 |