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.
FDA Recall Z-1901-2010 · Posted 2010-06-25
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Recalling FirmBio-Rad Laboratories Inc
Recall StatusTerminated
Product CodeLCP
Date Initiated2009-01-22
Date Terminated2011-03-22
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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