Bio-Rad Laboratories Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Bio-Rad Laboratories Inc
Lot Codes / Batch Numbers
version 4.0 software
Products Sold
version 4.0 software
Bio-Rad Laboratories Inc is recalling Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactur due to Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
Recommended Action
Per FDA guidance
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.
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