Z-1096-2022 Class II Ongoing
FDA device recall Z-1096-2022 was initiated by Bio-Rad Laboratories, Inc. on April 14, 2022 and is designated Class II. Reason for recall: Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack. The recall status is ongoing. Affected quantity: 348 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- April 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 348 units
Product Description
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Reason for Recall
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
Distribution Pattern
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.
Code Information
Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388