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U.S. Department of Health and Human Services

Class 3 Device Recall D10 Dual Program, Update Kit D10 A1c program diskette

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  Class 3 Device Recall D10 Dual Program, Update Kit D10 A1c program diskette see related information
Date Initiated by Firm November 22, 2013
Date Posted February 10, 2014
Recall Status1 Terminated 3 on March 20, 2014
Recall Number Z-0965-2014
Recall Event ID 66947
510(K)Number K031043  
Product Classification Assay, glycosylated hemoglobin - Product Code LCP
Product D-10 Dual Program, which contains Update Kit D-10 A1c program diskette.

United States; Bio-Rad Laboratories,
Hercules, CA 94547

The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromatography.
Code Information Catalog number: 220-0201: Reorder Pack Lot No./Expiration date: 20030322 3/31/2014 20030337 3/31/2014 64000081 5/31/2014  64000331 5/31/2014  64000332 5/31/2014 64000888 08/31/2014 64001344 04/30/2014 64002239 11/30/2014   ( 64002240 08/3112014  64002241 11/30/2014 
Recalling Firm/
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr
Hercules CA 94547-1803
For Additional Information Contact Ebony McKinnies
Manufacturer Reason
for Recall
D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.
FDA Determined
Cause 2
Software design
Action BIO-RAD sent an Urgent Medical Device Correction letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to use the affected update kit disk(s) included with the reorder pack(s), but manually track the number of injections on the cartridge, reviewing QC results closely throughout the life of the reorder pack or destroy the affected disk(s) included with these reorder pack(s) and replace with the new Update Kit disk(s) The new Update Kit disks will elminate the problem and may be used with all reorder packs. The replacement disks do not contain reagent or calibrator information; after installing teh new Update Kit disk, they ust manually update the component information using instructions provided with the disk. For questions regarding this recall call 510-741-6265.
Quantity in Commerce 2906 kits (318 Kits in US; 2588 kits internationally)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India.
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.