Class 2 Device Recall

• Date Initiated by Firm: November 08, 2002
• Date Posted: January 09, 2003
• Recall Status: Terminated on July 17, 2003
• Recall Number: Z-0415-03
• Recall Event ID: 25104
• 510(K)Number: K011342 K022161
• Product Classification: Counter, Differential Cell - Product Code GKZ
• Product: COULTER LH 700 Series Hematology Analyzers
• Code Information: Part number -6605632, No lot number applies, all serial numbers apply.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 South Kraemer Blvd W 337; Brea CA 92822
• For Additional Information Contact: Lynne McBride; 714-993-5321
• Manufacturer Reason for Recall: Software vote out logic changed. Erroneous white blood cell counts.
• FDA Determined Cause: Other
• Action: Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.
• Quantity in Commerce: 132
• 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