Company:Bio-Rad Laboratories, Inc.
Date of Enforcement Report 4/1/2009
Class:ll
PRODUCT
Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600. 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 # Z-1041-2009
REASON
Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by letter, fax and telephone on October 17, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
92 units
DISTRIBUTION
Nationwide and Internationally
