Vitros ECi Immunodiagnostic Intact PTH Reagent

Ortho received 166 world-wide complaints for Vitros iPTH reagent pack related to observations of lower-than-expected iPTH patient and quality control (QC) results with the affected lots listed above. Customers reported the negatively biased iPTH results when comparing results produced from the affected reagent lots to results produced from unaffected lots for patient correlation testing as well as assessing QC results from Biorad and Thermo Fisher.

Ortho's investigation compared results produced from affected reagent lots to results produced from unaffected reagent lots and confirmed an average -12% shift in patient sample results. Ortho's investigation included 119 patient samples, with patient sample concentrations ranging from 10 pg/ml - 2391 pg/ml, with the highest bias observed on an individual sample at approximately -26.7% and an overall estimated average bias of approximately -12%.

A variable negative shift in performance was also confirmed using Biorad Liquicheck/Lyphocheck Specialty Immunoassay controls and Thermo Scientific Mas Omni Immune Immunoassay controls when compared to their published assigned values. Vitros Immunodiagnostic products iPTH controls do not detect this bias, therefore no performance shifts of the controls were observed.

Recall start date: November 18, 2022