Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AQURE Recalled by Radiometer Medical ApS Due to There is a potential problem relating to the...

Date: February 27, 2018
Company: Radiometer Medical ApS
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer Medical ApS directly.

Affected Products

AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of 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 the user 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.

Quantity: 2

Why Was This Recalled?

There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Radiometer Medical ApS

Radiometer Medical ApS has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report