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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 System see related information
Date Initiated by Firm December 01, 2011
Date Posted March 21, 2012
Recall Status1 Terminated 3 on September 02, 2014
Recall Number Z-1243-2012
Recall Event ID 61255
510(K)Number K032000  
Product Classification Counter, differential cell - Product Code GKZ
Product COULTER LH 500 Series System ,

part number: LH500 System Help 2A4.103271;

LH 500 Series System 100V, PN 178832;
LH 500 Series System 120V, PN 178833;
LH 500 Series System 240V, PN 178834;
LH 500 Series System Remanufactured (115V), PN A91062;
LH 500 Series System Remanufactured (220V), PN A90994

SW Version 2A4, 2A5.
Serial Number: all.

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 LH 500 Analyzer also provides a semi-automated reticulocyte analysis.
Code Information Not available.
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 Coulter has confirmed that the Auto Stop and Auto Transmit features for Quality Control become disabled after scanning assay values from Coulter 5C and Retic-C Cell Controls assay sheets using the 2D Barcode scanner.
FDA Determined
Cause 2		 Software design
Action Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 30, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers who use the Auto-Stop or Auto-Transmit to ensure the settings are enabled in Control Setup after scanning the assay sheets. Additionally, a Response Form was included for customers to complete and return. Contact Beckman Coulter Customer Service at (800) 526-7694 for questions regarding this notice.
Quantity in Commerce 8,922 units total (4,073 units in US)
Distribution Worldwide Distribution-USA (nationwide) including the Virgin Islands and the countries of Algeria Andorra Angola Antigua and Barbuda Argentina Australia Bahrain Bangladesh Belgium Bermuda Brazil Bulgaria Burundi Cameroon Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador Egypt Ethiopia France Germany Greece Guadeloupe Guam Guatemala Honduras Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Macao Malaysia Mayotte Mexico Monaco Morocco Myanmar Namibia Netherlands New Zealand Norway Oman Pakistan Panama Philippines Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Trinidad and Tobago Tunisia Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam Yemen Zimbabwe
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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