Recall Z-1187-2021 ยท JZO System, Test, Thyroid Autoantibody
Tosoh Bioscience Inc
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 t
| Date | Feb 23, 2012 |
| Status | Terminated |
| Reason | Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable. |
| Root cause | Nonconforming Material/Component |
| Action | On 7/24/2012 the firm sent recall notificaiton letters to their customers. |
| Quantity | 34 boxess/2 sets/6 bottles |
| Distribution | US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981522 | AIA-PACK TGAB ASSAY Tosoh Medics, Inc., Oct 8, 1998 |