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.
FDA Recall Z-0695-2016 · Posted 2016-01-27
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Recalling FirmBio-Rad Laboratories, Inc.
Recall StatusTerminated
Product CodeLCP
Date Initiated2015-12-15
Date Terminated2016-05-02
Product Quantity165 in US, 200 Internationally
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.
Firm Action
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.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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