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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm November 19, 2004
Date Posted December 17, 2004
Recall Status1 Terminated 3 on March 24, 2005
Recall Number Z-0324-05
Recall Event ID 30530
Product Classification Radioimmunoassay, Immunoreactive Insulin - Product Code CFP
Product Immulite 2500 insulin Kit
Code Information lot 102A
Recalling Firm/
Manufacturer		 Diagnostic Products Corp
5210 Pacific Concourse Dr
Los Angeles CA 90045-6900
For Additional Information Contact Steve Iland
310-645-8200 Ext. 7434
Manufacturer Reason
for Recall		 Low bias of 10 to 40% at different levels of insulin in samples.
FDA Determined
Cause 2		 Other
Action Customers were notified by telephone on 11/19/2004. They were instructed to discard remaining kits.
Quantity in Commerce 10 kits
Distribution Medical facilities in AK, NY, WI.
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.
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