Company: Bio-Rad Laboratories, Inc
Date of Enforcement Report 5/27/2009
Class:ll

PRODUCT
Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000. Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in individuals with diabetes mellitus. Recall # Z-1395-2009

REASON
The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.

RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc. Hercules, CA, by telephone, fax and letter on December 10, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
42 units

DISTRIBUTION
Nationwide and Internationally