Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2

Recall date

July 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2580-2024

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2