# FDA recall Z-0469-2019

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

## Product

AIA-900 Analyzer, Product code 022930, 022930R

## Reason for recall

Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.

## Distribution

Distributed nationwide. Foreign distribution to Canada and Latin America.

## Key facts

- **Recall number:** Z-0469-2019
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-05
- **Report date:** 2018-11-21
- **Termination date:** 2020-11-10

- **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-0469-2019

## Citation

> AI Analytics. FDA recall Z-0469-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0469-2019. Source: US FDA. Licensed CC0.

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