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U.S. Department of Health and Human Services

Class 2 Device Recall D10 Dual Program

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 Class 2 Recall
D10 Dual Program
see related information
Date Posted January 25, 2007
Recall Status1 Terminated on November 28, 2007
Recall Number Z-0376-2007
Recall Event ID 37097
Premarket Notification
510(K) Number
K041444 
Product Classification Calibrator, Secondary - Product Code JIT
Product Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits.
Code Information Diluent lot number AA61508, Catalog number for recalled diluent: 220-0119, expiration date 11/30/07 Catalog number for whole kit: 220-0201. Reorder pack lot numbers 2006 1537, 2006 1555, 2006 1561, 2006 1557, 2006 1597, 2006 1600, 2006 1745, 2006 2007. Expiration dates on hte above catalog numbers: 04/30/2007, except for 2006 1557, which is 2/28/07. The diluent is packaged with either HbA1c Calibrators (cat number 220-0128, lot number S61409, exp. date 5/31/2007), or HbA2/F/A1c calibrators (cat number 220-218, exp date 5/31/07. Calibrator diluent that comes with the kit has an expiration date of AA61408
Recalling Firm/
Manufacturer
Bio-Rad Laboratories Inc
4000 Alfred Nobel Dr
Hercules, California 94547-1803
Manufacturer Reason
for Recall
The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.
Quantity in Commerce 900 kits, 43 sets distributed.
Distribution Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIT and Original Applicant = BIO-RAD LABORATORIES, INC.
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