# FDA recall Z-0599-2019

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2018-09-28.

## Product

AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R     The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

## Reason for recall

Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system.  If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error.  Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occurs, there may be a delay in testing and reporting patient test results. There have been no reports of injury related to this issue.

## Distribution

US Nationwide distribution and  International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador.

## Key facts

- **Recall number:** Z-0599-2019
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-28
- **Report date:** 2018-12-19
- **Termination date:** 2020-09-03

- **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-0599-2019

## Citation

> AI Analytics. FDA recall Z-0599-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0599-2019. Source: US FDA. Licensed CC0.

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