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U.S. Department of Health and Human Services

Class 2 Device Recall BioPlex 2200 ToRC IgM Reagent Pack

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  Class 2 Device Recall BioPlex 2200 ToRC IgM Reagent Pack see related information
Date Initiated by Firm April 14, 2022
Create Date May 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-1096-2022
Recall Event ID 90026
Product Classification Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
Product BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Code Information Model/Catalog Number: 12000670 UDI-DI (GTIN) Code: 03610520992715 Lot Number: 301388
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
6565 185th Ave Ne
Redmond WA 98052-5039
For Additional Information Contact Tina Cuccia
425-498-1758
Manufacturer Reason
for Recall		 Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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