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Bio-Rad Laboratories, Inc. recalls D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, proc
Recalled February 3, 2016 · FDA recall Z-0695-2016 · Bio-Rad Laboratories
Hazard
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. · FDA Class II
Units
165 in US, 200 Internationally
Sold at
Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, Belgium, Brazil, Brunei Darussalam, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Malaysia, Maldives, New Zealand, Norway, Austria, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, and UK.
Description
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.
Product
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.
Manufacturer(s)
Bio-Rad Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →