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U.S. Department of Health and Human Services

Class 2 Device Recall D10 Rack Loader

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  Class 2 Device Recall D10 Rack Loader see related information
Date Initiated by Firm December 15, 2015
Date Posted January 27, 2016
Recall Status1 Terminated 3 on May 02, 2016
Recall Number Z-0695-2016
Recall Event ID 72927
510(K)Number K060001  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
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.
Code Information All codes - 2006 to present
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Sweta Patel
510-741-5157
Manufacturer 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 2		 Software design
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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LCP and Original Applicant = BIO-RAD LABORATORIES, INC.
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