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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 FirmJune 20, 2005
Date PostedJuly 22, 2005
Recall Status1 Terminated 3 on March 07, 2012
Recall NumberZ-1041-05
Recall Event ID 32544
Product Classification Counter, Differential Cell - Product Code GKZ
ProductBeckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic Uint) 988610 (LH Connection Unit)
Code Information NA
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNancy E. Johnson
714-961-4489
Manufacturer Reason
for Recall		Risk of injury to workers due to mechanical or electrical hazards.
FDA Determined
Cause 2		Other
ActionLetters were sent advising of the hazard during the week of June 20, 2005 it stated that the units would be upgraded by appointment.
Quantity in Commerce34
DistributionUSA 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.
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