Tosoh Bioscience Inc: Medical Device Recall in 2021 - (Recall #: Z-1187-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: February 23, 2012

Date Posted: March 17, 2021

Recall Number: Z-1187-2021

Event ID: 76372

Reason for Recall:

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

Status: Terminated

Product Quantity: 34 boxess/2 sets/6 bottles

Code Information:

Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated