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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/
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 2
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 = and Original Applicant = BECKMAN COULTER, INC.
510(K)s with Product Code = and Original Applicant = COULTER CORP.
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