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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJanuary 10, 2003
Date PostedFebruary 05, 2003
Recall Status1 Terminated 3 on July 26, 2003
Recall NumberZ-0541-03
Recall Event ID 25454
510(K)NumberK011342 
Product Classification Counter, Differential Cell - Product Code GKZ
ProductCoulter LH 700 Series Hematology Analyzers
Code Information All lots.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information ContactLynne McBride
714-961-3626
Manufacturer Reason
for Recall		Biohazard situation exists for users.
FDA Determined
Cause 2		Other
ActionCustomers were sent letters instructing them to remove and replace affected pages in their manuals. Letters were sent January 10, 2003.
Quantity in Commerce210
DistributionNationwide and Canada.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKZ
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