Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmMay 03, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on July 01, 2004
Recall NumberZ-0972-04
Recall Event ID 29084
510(K)NumberK970877 
Product Classification System, Test, Carcinoembryonic Antigen - Product Code DHX
ProductImmulite 1000 CEA Catalog No. LKCE1
Code Information Lots 5 157 and 5 157L
FEI Number 3005250747
Recalling Firm/
Manufacturer		 Diagnostic Products Corp
5700 W 96th St
Los Angeles CA 90045-5544
For Additional Information ContactMarisa L. Meeks
310-645-8200
Manufacturer Reason
for Recall		Instabililty
FDA Determined
Cause 2		Other
ActionNotice was made via email or telephone. Users are to discard kits.
Quantity in Commerce884
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
-
-