QUIDELORTHO Recalls
2 recalls on record · May 22, 2024 to May 22, 2024 · Medical Devices
May 22, 2024Medical DevicesFDA
QUIDELORTHO recalls VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative meas
Hazard: Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.
May 22, 2024Medical DevicesFDA
QUIDELORTHO recalls VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (
Hazard: T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.