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Tosoh Bioscience Inc Recall 76372

Description: 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 Hashimoto s disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.

Tosoh Bioscience Inc Recall 76372 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-1187-2021
Event ID76372
Event DescriptionThyroglobulin 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 Hashimoto s disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
Quantity34 boxess/2 sets/6 bottles
Recall ReasonSome combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Device Classification20210317
Device Code InfoPart Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.
Center Classification Date20210308
Recall Initiation Date20120223
Recalling FirmTosoh Bioscience Inc
Initial Notification Letter
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