FDA-Device2024-03-13Class II
VITROS 3600 Immunodiagnostic System (New and Refurbished)
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
489 units (46 US, 443 OUS)
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1220-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief