# FDA recall Z-0602-2019

> **Tosoh Bioscience Inc** · Class II · device recall initiated 2017-09-28.

## Product

AIA-900 Automated Immunoassay Analyzer performs  three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.

## Reason for recall

The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported  D.lane Mix home overrun  error [4093] .     If observed, this issue will cause the AIA-900 Analyzer not to function and the  D.lane Mix home overrun  error [4093]  will be reported by the system. Replacement of the motor drive harness and mixing home detection sensor relay harness will mitigate the potential for premature wear and effectively prevent this issue from causing the system error.     If the sensor relay harness fails, the AIA-900 analyzer will cease to function and will be unavailable for use.  If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh is aware of two complaints ass

## Distribution

Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.

## Key facts

- **Recall number:** Z-0602-2019
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-28
- **Report date:** 2018-12-19
- **Termination date:** 2020-12-08

- **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-0602-2019

## Citation

> AI Analytics. FDA recall Z-0602-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0602-2019. Source: US FDA. Licensed CC0.

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