# FDA recall Z-1187-2021

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2012-02-23.

## 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.

## Distribution

US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.

## Key facts

- **Recall number:** Z-1187-2021
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2012-02-23
- **Report date:** 2021-03-17
- **Termination date:** 2021-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grove City, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1187-2021

## Citation

> AI Analytics. FDA recall Z-1187-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1187-2021. Source: US FDA. Licensed CC0.

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