Recall Z-1187-2021
Tosoh Bioscience Inc · initiated February 23, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873.
Reason for recall
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
FDA-determined cause: Nonconforming Material/Component
Action taken
On 7/24/2012 the firm sent recall notificaiton letters to their customers.
Details
- Recall number
- Z-1187-2021
- Initiated
- February 23, 2012
- Terminated
- July 8, 2021
- Product code
- JZO – System, Test, Thyroid Autoantibody
- Quantity
- 34 boxess/2 sets/6 bottles
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
- Recalling firm
- Tosoh Bioscience Inc, Grove City, OH