Class 3 Device Recall

• Date Initiated by Firm: February 23, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on December 02, 2004
• Recall Number: Z-0724-04
• Recall Event ID: 28501
• 510(K)Number: K013566
• Product Classification: Radioimmunoassay, Parathyroid Hormone - Product Code CEW
• Product: IMMULITE 2000 Intact PTH kit
• Code Information: Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
• 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 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: Other
• Action: Recall 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 Commerce: 2416 kits
• Distribution: North 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 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 = CEW and Original Applicant = DIAGNOSTIC PRODUCTS CORP.