Company: Bio-Rad Laboratories, In
Date of Enforcement Report 7/21//2010
Class ll:
PRODUCT
1) VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Provides an integrated method for sample preparation, separation and determination of the relative percent of specific hemoglobin in whole blood. Recall # Z-1901-2010;
2) VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A1C in EDTA human whole blood. Recall # Z-1902-2010.
REASON
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.
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated January 22, 2009 followed by telephone calls. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
397 units
DISTRIBUTION
Nationwide and Internationally
