# FDA recall Z-1394-2023

> **Radiometer Medical ApS** · Class II · device recall initiated 2023-03-08.

## Product

AQURE REF 933-599  Software Versions   2.5.2  2.5.3  2.5.4  2.6.0  2.6.1  The AQURE system is intended to let you manage analytical devices and operator profiles.  The user can associate patient data with test data. The system shows test results. The  system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be  managed. The AQURE system is intended for professional use.

## Reason for recall

Due to potential software issue that may result in patient mix-up information.

## Distribution

Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.

## Key facts

- **Recall number:** Z-1394-2023
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-08
- **Report date:** 2023-04-26

- **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-1394-2023

## Citation

> AI Analytics. FDA recall Z-1394-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1394-2023. Source: US FDA. Licensed CC0.

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