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Ortho-Clinical Diagnostics, Inc. recalls VITROS XT7600 Integrated System
Recalled March 13, 2024 · FDA recall Z-1222-2024 · Ortho-Clinical Diagnostics
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. · FDA Class II
Units
1,720 units (834 US, 886 OUS)
Sold at
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.
Description
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.
Product
VITROS XT7600 Integrated System
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →