Z-1582-2018Class II

AQURE, Software version 2.3.0 and 2.3.1

Name: Z-1582-2018 AQURE, Software version 2.3.0 and 2.3.1
Creator: Radiometer Medical ApS
Published: 2018-02-27
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2018-02-27 / Terminated / root cause: design

FDA source

Radiometer Medical ApS began a recall of 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... on 2018-02-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1582-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-27
Posted: 2018-03-14
Terminated: 2019-03-20
Recalling firm: Radiometer Medical ApS
Product: 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 code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: design
FDA root cause: Device Design
Action: Radiometer Medical sent a Notification letter dated February 27, 2018 to customers. The letter identified the affected product, problem and actions to be taken For questions contact your Radiometer representative.
Quantity in commerce: 2
Distribution: US Nationwide Distribution in the states to Georgia and Wisconsin.
Product codes and lots: Version 2.3.0 and 2.3.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1582-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1582-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01

Product code CHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)