medical Class II Updated 2018-10-10

Ortho Clinical Diagnostics Inc recalls VITROS Immunodiagnostic Products - Folate Reagent Pack(10758

Recalled Product

VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266


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

Distribution: Nationwide (United States)
Lot/Code Info: 2470 2480 2490 2501 2510 2521
View official government recall

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