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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 Analyzer see related information
Date Initiated by Firm January 31, 2011
Date Posted April 12, 2011
Recall Status1 Terminated 3 on September 25, 2012
Recall Number Z-1953-2011
Recall Event ID 57990
510(K)Number K011342  
Product Classification Counter, differential cell - Product Code GKZ
Product Coulter LH750 Analyzer

The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
Code Information part number: 6605632, A85570
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Clair K. O'Donovan, Ph.D.
714-993-5321
Manufacturer Reason
for Recall		 This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS if the year is greater than 2010. The following dates are affected: Run date, Control expiration date, Date of birth (For individuals born in 2011 or later), a
FDA Determined
Cause 2		 Software design
Action The firm, Beckman Coulter, sent an "URGENT: PRODUCTION CORRECTION" letter dated January 31, 2011 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Coulter LH 750 Analyzer, Coulter LH 780 Analyzer, Coulter LH 500 Series System, and Coulter GEN S System. The letter describes the product, problem and actions to be taken. The customers were instructed to work with their US vendor to assess how this affects their laboratory. The actions they choose are dependent on the configuration of their LIS. ACTION FOR ISSUE 1: Use Sample Drawn Date and Date of Birth information available at your LIS in lieu of the analyzer transmitted fields BIRTH and UDATE. Use the current date when the results are received at the LIS in lieu of the transmitted Run Date [DATE]. Print results from the Workstation to keep a copy of the analysis date on the analyzer, if necessary. Use the control expiration date from the analyzer display or printout. ACTION FOR ISSUE 2: If you use the LIS 1G1 transmission format, use the General Information group field names in place of the Retic Parameter group field names to identify each reticulocyte run (see Table in Issue 2 section). Check with your LIS vendor to determine if it is possible to switch to the LH 750 Workstation transmission format. Format requirements are LIS driver specific. For patients with Dates of Birth in 2011 for both Issue 1 and Issue 2, results should be reviewed to determine if decision rules or age-related limits sets were triggered inappropriately. RESOLUTION These issues will be corrected in a future software release for the LH Series products. The GEN¿¿S product has been discontinued; no software revisions will be forthcoming for the GEN¿¿S product line. Customers were also instructed to complete and return the PRODUCT CORRECTION RESPONSE FORM via fax to 786-639-7500/7501/7502/7503/7504; mail to Beckman Coulter, Inc., Attn: Regulatory Affairs Mail Code 310B06, 11
Quantity in Commerce 9419 (total units distributed in U.S. & foreign countries)
Distribution Worldwide distribution: USA (nationwide) and countries including: Algeria, Andorra, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bermuda, Bulgaria, Burundi, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Monaco, Morrocco, Myanmar, Namibia, Netherlands, 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, Vietnam, and Virgin Islands (US).
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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