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U.S. Department of Health and Human Services

Class 2 Device Recall Coulter LH500 Series Analyzer

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  Class 2 Device Recall Coulter LH500 Series Analyzer see related information
Date Initiated by Firm October 13, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on June 01, 2012
Recall Number Z-0599-2012
Recall Event ID 60367
510(K)Number K032000  
Product Classification Counter, differential cell - Product Code GKZ
Product Coulter LH500 Series Analyzer,
Part number: 178832, 178833, 178834.

LH 500 Series System Instructions for Use, PN 624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis.
Code Information N/A
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		 The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to contact Beckman Coulter Service at (800) 526-7694 if they were experiencing failures. Customers not experiencing failures, but their system may have the suspect chips, were told they would be contacted by Beckman Coulter Service to correct their problem. Customers were also instructed to complete and return an enclosed Response Form.
Quantity in Commerce 117 units total
Distribution Worldwide Distribution.
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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