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.
- Company
- Bio-Rad Laboratories Inc
- Recall Initiated
- October 17, 2008
- Posted
- March 24, 2009
- Terminated
- November 12, 2010
- Recall Number
- Z-1041-2009
- Quantity
- 92 units
- Firm Location
- Hercules, CA
Reason for Recall
Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
Distribution
Worldwide Distribution
Lot / Code Info
version 4.0 software
Root Cause
Pending
Action Taken
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.
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