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QuidelOrtho Issues Class II Recall of Vitros Free T3 Calibrators

NEW YORK – QuidelOrtho is recalling a reagent used with its Vitros immunodiagnostic test system, according to the US Food and Drug Administration. The product, called Free T3 Calibrators-IVD, is for use with the firm's Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine in human serum and plasma.

Free T3 testing is typically performed to aid in measuring thyroid function and diagnosing thyroid disease.

The calibrators may produce positively biased results for patient and quality control samples, according to an FDA webpage. The positive bias may in turn cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of other thyroid function tests.

The FDA has designated this a Class II recall, meaning use of or exposure to the product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse health consequences is remote.

QuidelOrtho issued a product correction notification on April 9 guiding customers to discontinue using certain lots of the calibrators, and the firm's investigation is ongoing. The calibrators are used with the Vitros Eci, ECiQ, 3600, 5600, XT, and 7600 systems.