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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 FirmMarch 31, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 30, 2012
Recall NumberZ-0905-04
Recall Event ID 28873
510(K)NumberK011342 
Product Classification Counter, Differential Cell - Product Code GKZ
ProductCoulter LH750 Hematology Analyzer. Part Number 6605632.
Code Information Software versions 2A2 and 2B1.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.
FDA Determined
Cause 2		Other
ActionA Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 2004.
Quantity in Commerce981
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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