Class 2 Device Recall UniCel DxI and DXC Immunoassay Systems

• Date Initiated by Firm: October 13, 2011
• Date Posted: August 23, 2012
• Recall Status: Terminated on August 23, 2012
• Recall Number: Z-2257-2012
• Recall Event ID: 62706
• 510(K)Number: K023764 K042291
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; ; Dxl 800 Remanufactured: A25288;; Dxl 800 with spot B: A71456;; Dxl 800 Reconditioned: A25285.; ; The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
• Code Information: Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285.
• 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 received seven reports of a software anomaly for the UniCel Dxl Immunoassay Systems. If undetected, this anomaly may cause erroneous test results.
• FDA Determined Cause: Software design
• Action: The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 with attached PCA Response Form to all customers who purchased the UniCel Dxl Immunoassay Systems and DxC Clinical Systems which includes all software versions. The letter describes the product, problem and actions to be taken. The customers were instructed verify the system temperatures immediately following each initialization; do not begin processing samples until this verification is complete; refer to the appendix included with the letter for detailed instructions about verifying system temperatures; review their quality control (QC) performance history; and share this information with their staff and retain this information as part of their quality system documentation, and to complete and return the enclosed response form within 10 days to Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318; Attn: Regulatory Affairs or fax to: 1-786-639-4000. Customers with any questions regarding the notice, were instructed to contact Customer Support Center via our website, http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representatives.
• Quantity in Commerce: 2442 units total (784 units in US)
• Distribution: Worldwide distribution: USA (nationwide) and countries of: Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea,Republic of; Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.
• 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 = JJE and Original Applicant = BECKMAN COULTER, INC.