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FDAJuly 12, 2018device

VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750000227

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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