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Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Recalled August 21, 2024 · FDA recall Z-2580-2024 · Ortho-Clinical Diagnostics
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. · FDA Class II
Units
18,467 units
Sold at
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.
Description
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.
Product
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →