Z-1582-2018 Class II Terminated
FDA device recall Z-1582-2018 was initiated by Radiometer Medical ApS on Feb 27, 2018 and is designated Class II. 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. The recall status is terminated (terminated Mar 20, 2019). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Feb 27, 2018
- Termination Date
- Mar 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
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.
Distribution Pattern
US Nationwide Distribution in the states to Georgia and Wisconsin.
Code Information
Version 2.3.0 and 2.3.1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1582-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026