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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER LH 500 Series System

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 Class 2 Device Recall COULTER LH 500 Series Systemsee related information
Date Initiated by FirmApril 18, 2007
Date PostedDecember 22, 2007
Recall Status1 Terminated 3 on April 16, 2012
Recall NumberZ-0314-2008
Recall Event ID 44916
510(K)NumberK032000 
Product Classification Beckman Coulter, Brea, CA. (Hematology analyzer) - Product Code GKZ
ProductCOULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA. (Hematology analyzer)
Code Information Part Number 178833. 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 Ext. 8383
Manufacturer Reason
for Recall		Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- When manually entering a Patient ID, if a blank space is entered between th
FDA Determined
Cause 2		Software design
ActionProduct Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.
Quantity in Commerce917 units in the US; 82 units to Canada
DistributionWorld wide: USA 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.
510(K) Database510(K)s with Product Code = GKZ
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