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.

Reason: 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.

Code information: Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285.

Distribution pattern: 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.