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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 FirmFebruary 14, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on December 02, 2004
Recall NumberZ-1027-04
Recall Event ID 28932
ProductDL 2000 Data Manager, Software Version 6.2
Code Information Version 6.2
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.
FDA Determined
Cause 2		Other
ActionRecall is complete. Letters were mailed to customers on 2/14/2003. Instruments received upated software version 6.3.
Quantity in Commerce231
DistributionNationwide.
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.
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