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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER LH750 Analyzer

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 Class 2 Device Recall COULTER LH750 Analyzersee related information
Date Initiated by FirmApril 18, 2007
Date PostedDecember 22, 2007
Recall Status1 Terminated 3 on April 16, 2012
Recall NumberZ-0312-2008
Recall Event ID 44916
510(K)NumberK011342 
Product Classification Beckman Coulter, Brea, CA. (Hematology analyzer) - Product Code GKZ
ProductCOULTER LH750 Analyzer, Part Number 6605632, Beckman Coulter, Brea, CA. (Beckman Coulter, Brea, CA. (Hematology analyzer)
Code Information Part Number 6605632. 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 Commerce2,214 units in US; 130 units in 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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