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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 01, 2004
Recall Number Z-0972-04
Recall Event ID 29084
510(K)Number k970877  
Product Classification System, Test, Carcinoembryonic Antigen - Product Code DHX
Product Immulite 1000 CEA

Catalog No. LKCE1
Code Information Lots 5 157 and 5 157L
Recalling Firm/
Manufacturer		 Diagnostic Products Corp
5700 W 96th St
Los Angeles CA 90045-5544
For Additional Information Contact Marisa L. Meeks
310-645-8200
Manufacturer Reason
for Recall		 Instabililty
FDA Determined
Cause 2		 Other
Action Notice was made via email or telephone. Users are to discard kits.
Quantity in Commerce 884
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 = DHX and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
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