Company: Bio-Rad Laboratories Inc.
Date of Enforcement Report 2/3/2016
D-10 Rack Loader; Model Number 220-0600; Hematology: 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-0695-2016
On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration..
Bio-Rad Laboratories, Inc., Hercules, CA on 12/15/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
165 in US, 200 Internationally
Nationwide and Internationally.