Class 3 Device Recall

• Date Initiated by Firm: September 08, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on March 30, 2004
• Recall Number: Z-0039-04
• Recall Event ID: 27251
• 510(K)Number: K992511
• Product Classification: Counter, Differential Cell - Product Code GKZ
• Product: Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604
• Code Information: All instruements are affected.
• FEI Number: 2050012
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 South Kraemer Blvd W 337; Brea CA 92822
• For Additional Information Contact: Kathleen M. Jaker; 714-961-3666
• Manufacturer Reason for Recall: Samples with high fat content will not count platelets accurately.
• FDA Determined Cause: Other
• Action: Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.
• Quantity in Commerce: 36
• Distribution: United States and Canada
• 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 = GKZ