Device Recall UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems

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)

Clinical Chemistry and Clinical Toxicology Devices

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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.

UniCel DxC 660i, 680i, 860i, 880i || SYNCHRON Access Clinical Systems; Part Number(s): DxC 660i: A64871, DxC 680i: A64903, || DxC860i: A64935, DxC 880i: A59102 || 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