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U.S. Department of Health and Human Services

Class 2 Device Recall Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager

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 Class 2 Device Recall Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Managersee related information
Date Initiated by FirmAugust 20, 2007
Date PostedAugust 08, 2008
Recall Status1 Terminated 3 on October 15, 2012
Recall NumberZ-1529-2008
Recall Event ID 46370
510(K)NumberK030828 
Product Classification Differential cell counter - IVD - Product Code GKZ
ProductCytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
Code Information All Software Versions
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNora Zerounian
714-961-3634
Manufacturer Reason
for Recall		Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
FDA Determined
Cause 2		Software design
ActionA Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.
Quantity in Commerce141 units
DistributionWorldwide Distribution --- including USA and country of 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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