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Terminated

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.

FDA Recall Z-1582-2018 · Posted 2018-03-14

Recalling FirmRadiometer Medical ApS
Recall StatusTerminated
Product CodeCHL
Date Initiated2018-02-27
Date Terminated2019-03-20
Product Quantity2

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states to Georgia and Wisconsin.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130144ABL90 FLEXRadiometer Medical Aps · 2013-07-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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