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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 July 31, 2003
Date Posted September 11, 2003
Recall Status1 Terminated 3 on December 30, 2003
Recall Number Z-1219-03
Recall Event ID 27020
510(K)Number k000463  
Product Classification Helicobacter Pylori - Product Code LYR
Product Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
Code Information Lot 118
Recalling Firm/
Manufacturer		 Diagnostic Products Corp
5700 West 96th Street
Los Angeles CA 90045
For Additional Information Contact Irene M. Guzman
310-645-8200
Manufacturer Reason
for Recall		 Kits had parts in them that did not belong in the kit.
FDA Determined
Cause 2		 Other
Action Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003.
Quantity in Commerce 339
Distribution US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria
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 = LYR and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
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