Company: Bio-Rad Laboratories, Inc.
Date of Enforcement Report:2/19/2014
Class lI:
PRODUCT
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
Recall Number Z-0965-2014
REASON
D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc..,Hercules, CA on 11/22/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2906 kits (318 Kits in US; 2588 kits internationally)
DISTRIBUTION
Nationwide and Internationally
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