Recall Z-2982-2020 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Bio-Rad Laboratories, Inc.
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
| Date | Apr 21, 2020 |
| Status | Open, Classified |
| Reason | The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650. |
| Root cause | Unknown/Undetermined by firm |
| Action | Consignees that have purchased active lots of the BioPlex 2200 Syphilis Total and RPR kit have been notified of the Field Correction via a customer letter sent via Fed Ex overnight ; date issued 04/21/2020. The communication was to inform that the RPR portion of the BioPlex 2200 Syphilis Total & RPR assay will be temporarily disabled. The RPR assay will be disabled beginning with reagent lot 301142 of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). The reporting of the RPR assay resu |
| Quantity | 12000 kits |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), Fr |
| 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 |