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U.S. Department of Health and Human Services

Class 2 Device Recall VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5

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  Class 2 Device Recall VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5 see related information
Date Initiated by Firm January 22, 2009
Date Posted June 25, 2010
Recall Status1 Terminated 3 on March 22, 2011
Recall Number Z-1901-2010
Recall Event ID 51498
510(K)Number K984268  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA.

Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobins in whole blood.

Code Information All units of these models.
Recalling Firm/
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Jackie Buckley
Manufacturer Reason
for Recall
Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
FDA Determined
Cause 2
Software design
Action Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution. For further information, contact Bio-Rad Laboratories at 1-510-724-7000.
Distribution Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Poland, Singapore, South Korea, Sweden, Taiwan, Thailand and the United Kingdom.
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