# FDA recall Z-1850-2019

> **Arkray Factory USA, Inc.** · Class II · device recall initiated 2019-05-03.

## Product

AUTION HYBRID AU-4050

## Reason for recall

This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur:   1) No measurement results are generated due to an error by a urine sediment measurement.  2) The instrument is shutdown incorrectly.  3) An item rack is used for subsequent sample measurements.

## Distribution

US

## Key facts

- **Recall number:** Z-1850-2019
- **Recalling firm:** Arkray Factory USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-03
- **Report date:** 2019-06-26
- **Termination date:** 2020-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1850-2019

## Citation

> AI Analytics. FDA recall Z-1850-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1850-2019. Source: US FDA. Licensed CC0.

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