BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
- Company
- Bio-Rad Laboratories, Inc
- Recall Initiated
- April 14, 2022
- Recall Number
- Z-1096-2022
- Quantity
- 348 units
- Firm Location
- Redmond, WA
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
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.
Lot / Code Info
Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388
Root Cause
Under Investigation by firm
Action Taken
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 occurrences of the issue. Customers are instructed to immediately discontinue use and to dispose of any unused product of Lot No. 301388. If the affected lot has been further distributed or transferred the product to other Bio-Rad customers, or labs, these customer/labs should be notified of this field action/recall. For questions or further assistance, contact local Bio-Rad Technical Support.