Bio-Rad Laboratories Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bio-Rad Laboratories Inc
Lot Codes / Batch Numbers
All units of these models.
Products Sold
All units of these models.
Bio-Rad Laboratories Inc is recalling VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Prod due to Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube positi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026