Tosoh Bioscience Inc recalls Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitativ…

Recall date

February 23, 2012

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1187-2021

FDA classification

Class II

Brand / firm

Tosoh Bioscience Inc

Sold / distributed

US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.

Why it was recalled

Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.