Class 2 Device Recall Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader

• Date Initiated by Firm: December 14, 2010
• Date Posted: March 18, 2011
• Recall Status: Terminated on September 02, 2014
• Recall Number: Z-1730-2011
• Recall Event ID: 57757
• 510(K)Number: K010765
• Product Classification: Differential Cell Counter - Product Code GKZ
• Product: Coulter HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader.; ; Hematology Analyzers; Part Number: 6605522, 6605523, 6605524, 6605525, 6605526, 6605527, A85566, and A85564.; ; Quantitative, automated hematology analyzer and leukocyte differential cell; counter for In Vitro Diagnostic Use in clinical laboratories.
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Clair K. O'Donovan, Ph.D.; 714-961-4483
• Manufacturer Reason for Recall: The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a barcode label scanned by the primary mode barcode reader. There is a potential for Specimen or Patient misidentification to occur.
• FDA Determined Cause: Other
• Action: The recall communication was initiated on 12/14/2010 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the COULTER HmX Hematology Analyzer, COULTER HmX Hematology Analyzer with Autoloader, COULTER MAXM Analyzer, COULTER MAXM Hematology Analyzer with Autoloader. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed not to use the tilde (~) character in Specimen or Patient identifiers. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
• Quantity in Commerce: 4288 units total
• Distribution: Worldwide Distribution -- US, Algeria, Andorra, Antigua and Barbuda, Australia, Austria, Bahrain, Bangladesh, Bermuda, Bosnia and Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Canada, Cayman Islands, China, Congo, Cote d'Ivoire, Croatia, Czech Republic, Djibouti, Egypt, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Latvia, Lebanon, Libyan Arab, Jamahiriya, Lithuania, Macao, Malawi, Mexico, Mongolia, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sudan, Swaziland, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, U.S. Virgin Islands, Yemen, and Zambia.
• 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.