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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 FirmApril 28, 2003
Date PostedJuly 30, 2003
Recall Status1 Terminated 3 on April 20, 2004
Recall NumberZ-1070-03
Recall Event ID 26359
ProductCyto-Stat/Coulter Clone B6-RD, Part number 6604426.
Code Information Lot numbers 737312, 737313, 737314, 737315.
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information ContactKathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results.
FDA Determined
Cause 2		Other
ActionCustomer letters will be sent to all known purchasers on or about 4/28/2003, also existing inventory will be reworked to include a letter describing performance issues when collection occurs using EDTA.
Quantity in Commerce1053 kits
DistributionNationwide and to 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.
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