Medical Device Recall: VITROS 3600 Immunodiagnostic System (New and Refurbished)
Ortho-Clinical Diagnostics, Inc. · January 22, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
489 units (46 US, 443 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1220-2024
Status: ongoing
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