Quidelortho FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to QDEL.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measClass IIApr 9, 2024Free T3 Calibrators used with T3 Reagent Packs may produce p	Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality c	Class IIDevices	Apr 9, 2024
VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (Class IIApr 9, 2024T3 Reagent Packs used with Free T3 Calibrators may produce p	T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality c	Class IIDevices	Apr 9, 2024