# FDA recall Z-0682-2019

> **Radiometer America Inc** · Class II · device recall initiated 2018-07-03.

## Product

ABL800 analyzer, model numbers 393-800 and 393-801.

## Reason for recall

The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

## Distribution

Distribution was nationwide.  There was also military/government distribution.  Foreign distribution was made to Canada.

## Key facts

- **Recall number:** Z-0682-2019
- **Recalling firm:** Radiometer America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-03
- **Report date:** 2019-01-02
- **Termination date:** 2023-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0682-2019

## Citation

> AI Analytics. FDA recall Z-0682-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0682-2019. Source: US FDA. Licensed CC0.

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