Radiometer America Inc: Medical Device Recall in 2016 - (Recall #: Z-0899-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 23, 2016

Date Posted: December 28, 2016

Recall Number: Z-0899-2017

Event ID: 75836

Reason for Recall:

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

Status: Terminated

Product Quantity: 7 total (2 in US)

Code Information:

UDI: (01)05700699335999(10)2.2.0

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated