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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm December 10, 2002
Date Posted February 25, 2003
Recall Status1 Terminated 3 on April 21, 2004
Recall Number Z-0571-03
Recall Event ID 25484
510(K)Number k962988  k011342  
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/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Lynne McBride
Manufacturer Reason
for Recall
Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
FDA Determined
Cause 2
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 = and Original Applicant = BECKMAN COULTER, INC.
510(K)s with Product Code = and Original Applicant = COULTER CORP.