Bio-Rad Laboratories, Inc. Recall 90026
Description: BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Bio-Rad Laboratories, Inc. Recall 90026 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1096-2022 |
| Event ID | 90026 |
| Event Description | BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack |
| Product Type | Devices |
| 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. |
| Quantity | 348 units |
| Recall Reason | Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack. |
| Device Classification | 20220525 |
| Device Code Info | Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388 |
| Center Classification Date | 20220516 |
| Recall Initiation Date | 20220414 |
| Recalling Firm | Bio-Rad Laboratories, Inc. |
| Initial Notification | Letter |
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