Class 3 Device Recall

• Date Initiated by Firm: December 10, 2002
• Date Posted: February 25, 2003
• Recall Status: Terminated on April 21, 2004
• Recall Number: Z-0571-03
• Recall Event ID: 25484
• 510(K)Number: K011342 K962988
• Product: Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
• Code Information: In the LH 700 series, all serial numbers up to AE1088. In the GENS series, all instruments.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 South Kraemer Blvd W 337; Brea CA 92822
• For Additional Information Contact: Lynne McBride; 714-961-3626
• Manufacturer Reason for Recall: Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
• FDA Determined Cause: Other
• Action: Firm will check and shorten sweepflow tubing on a next visit basis during routine service visits.
• Quantity in Commerce: 447
• Distribution: Nationwide and Canada

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 = ; 510(K)s with Product Code =