Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922

Recall date

July 12, 2018

Source

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

Recall number

Z-0059-2019

FDA classification

Class II

Brand / firm

Ortho Clinical Diagnostics Inc

Sold / distributed

Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.

Why it was recalled

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

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 Products - FSH Reagent Pack (10758750000302) 1931922