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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJanuary 20, 2003
Date PostedFebruary 25, 2003
Recall Status1 Terminated 3 on July 26, 2003
Recall NumberZ-0570-03
Recall Event ID 25485
510(K)NumberK003677 
ProductAcT 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter
Code Information Not applicaable.
FEI Number 2050012
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		Failure to cycle properly ammong samples.
FDA Determined
Cause 2		Other
ActionCustomers were sent a letter dated January 20, 2003 that describes this situation and provides modified operating instructions to prevent the occurence.
Quantity in Commerce351
DistributionUS 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.
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