Company Bio-Rad Laboratories, Inc.
Date of Enforcement Report:4/2/2014
Class lI:
PRODUCT
D-10″ Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis. Recall Number Z-1299-20144
REASON
On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample..
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA on.2/27/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
483 instruments in US. OUS to be determined.
DISTRIBUTION
Nationwide and Internationally
___________________________________
