Device Recall VITROS 250 Chemistry System

Software Version 9.4 and below; VITROS 250 Serial Numbers: 25010043 - 25055306; VITROS 250 Refurbished Serial Numbers: 25010582, 25010617, 25010638, 25010782, 25011056, 25011074, 25011176, 25011192, 25011196, 25011246, 25011317, 25011383, 25011408, 25011435, 25011448, 25011517, 25011647, 25011648, 25011777, 25011957, 25012025, 25012058, 25012062, 25012073, 25012078, 25012140, 25012259, 25012267, 25012323, 25012344, 25012487, 25012505, 25012521, 25012574, 25012629, 25012654, 25012672, 25012765, 25012782, 25012838, 25012931, 25012938, 25013036, 25013100, 25013139, 25013216, 25013245, 25013313, 25013389, 25013391, 25013448, 25013473, 25013497, 25013583, 25013597, 25013719, 25013757, 25013787, 25013790, 25013870, 25013879, 25013971, 25013982, 25014033, 25014196, 25014201, 25014209, 25014272, 25014278, 25014286, 25014318, 25014404, 25014409, 25014412, 25014448, 25014449, 25014459, 25014562, 25014609, 25014610, 25014655, 25014657, 25014663, 25014728, 25014741, 25014775, 25014788, 25014832, 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Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US Nationwide including Puerto Rico, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela

VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. || Product Usage: || For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.