Device 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.
Z-1187-2021
Product summary
- Event
- Event 76372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 boxess/2 sets/6 bottles
- Official record key
device-enforcement:Z-1187-2021
Official wording
Reason: Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
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.
Derived failure modes
-
Unknown
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.