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U.S. Department of Health and Human Services

Class 2 Device Recall COULTER LH 500 Hematology Analyzer

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  Class 2 Device Recall COULTER LH 500 Hematology Analyzer see related information
Date Initiated by Firm August 12, 2004
Date Posted September 02, 2004
Recall Status1 Terminated 3 on April 26, 2012
Recall Number Z-1433-04
Recall Event ID 29880
510(K)Number K032000  
Product Classification Counter, Differential Cell - Product Code GKZ
Product COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis.
Code Information Part Numbers: 178832, 178833, and 178834 software versions 1A and 1A2.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Kathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		 Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a predilute sample result.
FDA Determined
Cause 2		 Other
Action Customers were notified via U.S. mail by a Product Corrective Action Letter (PCA) dated August 12, 2004. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occurring.
Quantity in Commerce 222
Distribution Nationwide & Canada
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GKZ and Original Applicant = BECKMAN COULTER, INC.
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