Recall Z-1096-2022 ยท LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Bio-Rad Laboratories, Inc.
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
| Date | Apr 14, 2022 |
| Status | Open, Classified |
| Reason | Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack. |
| Root cause | Under Investigation by firm |
| Action | On 04/14/2022, Bio-Rad Laboratories sent an "URGENT: Medical Device Recall" letter via FedEx to customers informing them that Bio-Rad has identified a performance concern for the CMV IgM analyte in the BioPlex 2200 ToRC IgM kit lot 301388. The CMV IgM analyte has demonstrated variable elevated background depending on the handling of the reagent pack. Agitation of the conjugate within the reagent pack has demonstrated a potential for both false negative and false positive results for the CMV IgM assay. QC failures may prevent the release of incorrect results; however, QC may not detect all occu |
| Quantity | 348 units |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.