# FDA recall Z-0601-2019

> **Tosoh Bioscience Inc** · Class III · device recall initiated 2018-10-05.

## Product

Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.

## Reason for recall

Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim.  If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control.  If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.

## Distribution

Distributed nationwide. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-0601-2019
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-05
- **Report date:** 2018-12-19
- **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-0601-2019

## Citation

> AI Analytics. FDA recall Z-0601-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0601-2019. Source: US FDA. Licensed CC0.

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