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.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- January 22, 2009
- Posted
- June 25, 2010
- Terminated
- March 22, 2011
- Recall Number
- Z-1901-2010
- Firm Location
- Hercules, CA
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.
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.
Lot / Code Info
All units of these models.
Root Cause
Software design
Action Taken
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.