# FDA recall Z-1809-2018

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

## Product

Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218    The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.

## 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-1809-2018
- **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-1809-2018

## Citation

> AI Analytics. FDA recall Z-1809-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1809-2018. Source: US FDA. Licensed CC0.

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