Company:Bio-Rad, Laboratories Inc
Date of Enforcement Report 5/18/2011
Class ll:
PRODUCT
Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. a) Catalog Numbers: 270-2415 and b) 270-2417; The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only–For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ion?exchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-?throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software. Recall # Z-1932-2011
REASON
Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated December 1, 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1099 units
DISTRIBUTION
Nationwide and Internationally
