Radiometer Medical ApS: Medical Device Recall in 2018 - (Recall #: Z-1582-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 27, 2018

Date Posted: May 9, 2018

Recall Number: Z-1582-2018

Event ID: 79411

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2

Code Information:

Version 2.3.0 and 2.3.1

Distribution Pattern:

US Nationwide Distribution in the states to Georgia and Wisconsin.

Voluntary or Mandated:

Voluntary: Firm initiated