Class 2 Device Recall UniCel DxI 800 Access Immunoassay Systems

• Date Initiated by Firm: January 26, 2011
• Date Posted: April 11, 2011
• Recall Status: Terminated on June 04, 2012
• Recall Number: Z-1938-2011
• Recall Event ID: 57952
• 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 Number(s): DxI 800: 973100, DxI 800 Remanufactured A25288, DxI 800 with spot B A71456, DxI 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: DxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only)
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Clair K. ODonovan, Ph.D.; 714-961-4483
• Manufacturer Reason for Recall: The recall was initiated due to Beckman Coulter receiving a report of results that were associated with incorrect patient identifications when two sample racks advanced into the sample presentation area in one push. The first rack of the two was not scanned. This is referred to as a "pushed pair." If a pushed pair event occurs, results may be associated with the incorrect patient identification.
• FDA Determined Cause: Pending
• Action: Beckman Coulter sent an Urgent: Field Safety Notice Product Correction letter dated January 26, 2011, via US Postal Service to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: 1. To prevent a pushed pair, be sure your sample racks are free of debris prior to use. Do not apply additional labels to the sample racks. Extra labels can obscure the edges of a sample rack, or obstruct the gap between two racks. Be sure sample labels do not extend beyond the edges of a sample rack; 2. If a pushed pair occurs on the UniCel DxI system, the system generates a yellow Event Log message - Clear the presentation tray and press ROUTINE button. This Event Log message is associated with a variety of common Sample Presentation Unit (SPU) errors. For that reason, you must review the Event Log details to confirm the pushed pair event has not occurred; 3. Detach the Appendix included with this notification and store it near your UniCel DxI system. Use the Appendix as a reference if you suspect a pushed pair event has occurred on your system. Beckman Coulter also requested their customers share the recall information with their laboratory staff, and retain pages 1 and 2 of this notification as part of your laboratory Quality System documentation. For questions regarding ththe recall notification, customers were instructed to contact Beckman Coulter Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support, or call 1-800-854-3633 in the United States or Canada. Outside the United States and Canada, contact their local Beckman Coulter Representative.
• Quantity in Commerce: 2639 units (892 in US)
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, 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 Vietnam.
• 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