FDA-Device2024-03-13Class II
VITROS XT 7600 Integrated System, Catalog No. 6844461
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
142 US; 78 OUS
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS XT 7600 Integrated System, Catalog No. 6844461
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2024Don't want to check this manually?
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