Radiometer America Inc recalls AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE…

Recall date

November 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0899-2017

FDA classification

Class II

Brand / firm

Radiometer America Inc

Sold / distributed

Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.

Why it was recalled

Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage 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 you 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.