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U.S. Department of Health and Human Services

Class 2 Device Recall BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0

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  Class 2 Device Recall BioRad Variant II TURBO Hemoglobin Testing System with CDM v 4.0 see related information
Date Initiated by Firm October 17, 2008
Date Posted March 24, 2009
Recall Status1 Terminated 3 on November 12, 2010
Recall Number Z-1041-2009
Recall Event ID 50174
510(K)Number K063400  
Product Classification Glycosylated Hemoglobin Assay - Product Code LCP
Product Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Laboratories, Hercules, CA

Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c.
Code Information version 4.0 software
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact
510-724-7000
Manufacturer Reason
for Recall		 Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
FDA Determined
Cause 2		 Pending
Action An Urgent Medical Device Correction letter was sent out on October 17, 2008 via fax and phone call. The letter recommended that customers review the Summary Report for duplicate tube position numbers or barcode IDs within the same rack. If there are questions or a need for assistance, customers are to contact their regional Bio-Rad office. Follow-ups will be made once root cause is identified.
Quantity in Commerce 92 units
Distribution Worldwide Distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LCP and Original Applicant = BIO-RAD LABORATORIES, INC.
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