FDA-Device2020-09-02Class II
VITROS XT7600 Integrated System, Product code 6844461
Ortho Clinical Diagnostics
Hazard
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Affected count
pending
Manufactured in
100 Indigo Creek Dr, N/A, Rochester, NY, United States
Products
VITROS XT7600 Integrated System, Product code 6844461
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2879-2020Don't want to check this manually?
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