Class 2 Device Recall

• Date Initiated by Firm: March 31, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on April 30, 2012
• Recall Number: Z-0905-04
• Recall Event ID: 28873
• 510(K)Number: k011342
• Product Classification: Counter, Differential Cell - Product Code GKZ
• Product: Coulter LH750 Hematology Analyzer. Part Number 6605632.
• Code Information: Software versions 2A2 and 2B1.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 S Kraemer Blvd; Brea CA 92822-6208
• For Additional Information Contact: Kathleen M. Jaker; 714-961-3666
• Manufacturer Reason for Recall: If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.
• FDA Determined Cause: Other
• Action: A Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 2004.
• Quantity in Commerce: 981
• 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 and Original Applicant = BECKMAN COULTER, INC.