FDA-Device2024-03-13Class II
VITROS XT7600 Integrated System
Ortho-Clinical Diagnostics, Inc.
Hazard
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
Affected count
1,720 units (834 US, 886 OUS)
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS XT7600 Integrated System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2024Don't want to check this manually?
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