# FDA recall Z-0864-2020

> **Radiometer Medical ApS** · Class II · device recall initiated 2019-08-08.

## Product

AQURE basic sytem, FLEXLINK, REF 933-599,  Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999    Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.

## Reason for recall

The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.

## Distribution

Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; and countries of:  Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Italy, Japan (Tokyo-not a country but it was listed), Netherlands, Norway, Poland, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.

## Key facts

- **Recall number:** Z-0864-2020
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-08
- **Report date:** 2020-02-05
- **Termination date:** 2022-06-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bronshoj, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0864-2020

## Citation

> AI Analytics. FDA recall Z-0864-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0864-2020. Source: US FDA. Licensed CC0.

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