Thyroglobulin Antibody — Class II medical device recall Z-1187-2021
Terminated recall by Tosoh Bioscience Inc, reported 2021-03-17, distributed nationwide. Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the ca
| Recall number | Z-1187-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2012-02-23 |
| Classified | 2021-03-08 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2021-07-08 |
| Distributed | Nationwide (US) |
| Lot numbers | B834868, BX34869, C234871, C434872, C534873 |
| Model numbers | 020391 |
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.
Reason for recall
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1187-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.