Class 3 Device Recall

• Date Initiated by Firm: July 31, 2003
• Date Posted: September 11, 2003
• Recall Status: Terminated on December 30, 2003
• Recall Number: Z-1219-03
• Recall Event ID: 27020
• 510(K)Number: K000463
• Product Classification: Helicobacter Pylori - Product Code LYR
• Product: Immulite 2000 H. pylori IgG Kit lot 118 (L2KHQ6, 600 test size kit)
• Code Information: Lot 118
• FEI Number: 3005250747
• Recalling Firm/ Manufacturer: Diagnostic Products Corp; 5700 West 96th Street; Los Angeles CA 90045
• For Additional Information Contact: Irene M. Guzman; 310-645-8200
• Manufacturer Reason for Recall: Kits had parts in them that did not belong in the kit.
• FDA Determined Cause: Other
• Action: Customers have been informed to discard kits with the incorrect adjustors in them by fax delivered on 7/31/2003.
• Quantity in Commerce: 339
• Distribution: US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria
• 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 = LYR