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
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1187-2021 |
| Event ID | 76372 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR. |
| Quantity | 34 boxess/2 sets/6 bottles |
| Recall Reason | Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable. |
| Device Classification | 20210317 |
| Device Code Info | Part Number 020391; Lot # B834868, Lot # BX34869, Lot # C234871, Lot # C434872 & Lot # C534873. |
| Center Classification Date | 20210308 |
| Recall Initiation Date | 20120223 |
| Recalling Firm | Tosoh Bioscience Inc |
| Initial Notification | Letter |
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