# FDA recall Z-0485-2019

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

## Product

Tosoh AIA-900 immunoassay Analyzer

## Reason for recall

A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later) to fix the problem. This failure is mitigated by the hardware design. The consequence would be a slight delay in testing patient sample or reporting patient result.

## Distribution

Distributed to accounts in GA and NY.

## Key facts

- **Recall number:** Z-0485-2019
- **Recalling firm:** Tosoh Bioscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-28
- **Report date:** 2018-11-28
- **Termination date:** 2020-07-08

- **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-0485-2019

## Citation

> AI Analytics. FDA recall Z-0485-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0485-2019. Source: US FDA. Licensed CC0.

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