Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products - TSH Reagent Pack (107587
Recalled Product
VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
Hazard / Issue
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.
Issued by
FDA
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