VITROS XT 3400 Chemistry System, Catalog No. 6844458

Reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

Code information: VITROS System Software Version 3.8.1 UDI-DI 10758750031986 Serial Numbers US: J34500180 J34500289 J34500422 J34500473 J34500622 J34500861 J34500887 OUS: J34500515 J34500609 J34500802 J34500940

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.