FDA (Devices) recall action 80717
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ortho Clinical Diagnostics is recalling VITROS FSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than indicated.
Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.
Ortho Clinical Diagnostics is recalling VITROS Folate Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated.
Ortho Clinical Diagnostics is recalling VITROS Prolactin Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.