FDA-Device2024-08-21Class II
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Ortho-Clinical Diagnostics, Inc.
Hazard
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Sweden, United Kingdom.
Affected count
18,467 units
Manufactured in
100 Indigo Creek Dr, Rochester, NY, United States
Products
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2024Don't want to check this manually?
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