Ortho-Clinical Diagnostics, Inc.: VITROS XT 3400 Chemistry System, Catalog No. 6844458

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 7 US; 4 OUS Lot/code info: 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

UPC codes

10758750031986

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.