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Tosoh Bioscience Inc recalls Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitativ
Recalled March 17, 2021 · FDA recall Z-1187-2021 · Tosoh Bioscience
Hazard
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable. · FDA Class II
Units
34 boxess/2 sets/6 bottles
Sold at
US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
Description
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Product
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
Manufacturer(s)
Tosoh Bioscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →