FDA-Device2024-03-13Class II
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Ortho-Clinical Diagnostics, Inc.
Hazard
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Affected count
25 US; 26 OUS
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS XT 3400 Chemistry System, Catalog No. 6844458
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2024Don't want to check this manually?
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