Recall Z-0695-2016
Bio-Rad Laboratories, Inc. · initiated December 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: All codes - 2006 to present
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.
FDA-determined cause: Software design
Action taken
Urgent Medical Device Correction letters were sent on December 2015 to all affected consignees and subsidiaries. Each subsidiary will be given a Subsidiary Medical Device Correction Notice, Customer Medical Device Correction Notice, and Return Response Form and the number of customers distributed by e-mail. Each Subsidiary much contact customers and translate the Customer Medical Device Correction Notice and Return Response Form as needed. A revised letter to subsidiaries and customers was sent on January 20, 2016.
Details
- Recall number
- Z-0695-2016
- Initiated
- December 15, 2015
- Posted by FDA
- January 27, 2016
- Terminated
- May 2, 2016
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 165 in US, 200 Internationally
- Distribution
- 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.
- Recalling firm
- Bio-Rad Laboratories, Inc., Hercules, CA