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Ortho-Clinical Diagnostics, Inc. recalls VITROS 3600 Immunodiagnostic System (New and Refurbished)
Recalled March 13, 2024 · FDA recall Z-1220-2024 · 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
489 units (46 US, 443 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 3600 Immunodiagnostic System (New and Refurbished)
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →