Z-0695-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2016
- Initiation Date
- December 15, 2015
- Termination Date
- May 2, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165 in US, 200 Internationally
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
All codes - 2006 to present