# FDA recall Z-1810-2018

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2018-03-05.

## Product

Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318    The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.

## Reason for recall

The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.

## Distribution

USA (nationwide) Distribution including PR and to the states of :  AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

## Key facts

- **Recall number:** Z-1810-2018
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-05
- **Report date:** 2018-05-23
- **Termination date:** 2020-06-16

- **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-1810-2018

## Citation

> AI Analytics. FDA recall Z-1810-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1810-2018. Source: US FDA. Licensed CC0.

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