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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmFebruary 23, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on December 02, 2004
Recall NumberZ-0724-04
Recall Event ID 28501
510(K)NumberK013566 
Product Classification Radioimmunoassay, Parathyroid Hormone - Product Code CEW
ProductIMMULITE 2000 Intact PTH kit
Code Information Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
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 Ext. 2006
Manufacturer Reason
for Recall		High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.
FDA Determined
Cause 2		Other
ActionRecall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.
Quantity in Commerce2416 kits
DistributionNorth America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC
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 = CEW
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