Class 2 Device Recall

• Date Initiated by Firm: April 20, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 02, 2005
• Recall Number: Z-0987-04
• Recall Event ID: 28957
• 510(K)Number: K030291
• Product Classification: Counter, Differential Cell - Product Code GKZ
• Product: Coulter AcT 5diff Autoloader (AL) Hematology Analyzer
• Code Information: All software versions (1.00 & 1.20)
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 S Kraemer Blvd; Brea CA 92822-6208
• For Additional Information Contact: Kathleen Jaker; 714-961-3666
• Manufacturer Reason for Recall: Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the same parameter.
• FDA Determined Cause: Other
• Action: Firm sent recall letter on or about April 20, 2004 informing users of the issue. Firm will implement a software solution in the near future.
• Quantity in Commerce: 70
• Distribution: Nationwide 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