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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 26, 2005
Date PostedJuly 16, 2005
Recall Status1 Terminated 3 on February 03, 2006
Recall NumberZ-1015-05
Recall Event ID 32268
510(K)NumberK970877 
Product Classification System, Test, Carcinoembryonic Antigen - Product Code DHX
ProductImmulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Code Information Lots 302 and 303
FEI Number 3005250747
Recalling Firm/
Manufacturer		 Diagnostic Products Corp
5210 Pacific Concourse Dr
Los Angeles CA 90045-6900
For Additional Information ContactSteve Iland
310-645-8200 Ext. 7434
Manufacturer Reason
for Recall		Adverse trend in stability, controls biased or out of range.
FDA Determined
Cause 2		Other
ActionRecall was initiated by phone using a script, to be followed up with a letter and response form.
Quantity in Commerce269
DistributionNationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DHX
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