The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1582-2018·Announced 2018-05-09

Radiometer AQURE Software Recalled for Potential Patient Data Mix-Up

Radiometer Medical ApS is recalling AQURE software versions 2.3.0 and 2.3.1 due to a potential problem that may result in patient mix-up.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical software) where a patient mix-up could lead to serious consequences, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Radiometer Medical ApS is recalling AQURE software versions 2.3.0 and 2.3.1. The AQURE system is intended for professional use to manage analytical devices and operator profiles, associate patient data with test data, and display test results. The system receives data from connected devices at the point-of-care or laboratory and can send results to the HIS/LIS.

The recall is being issued because there is a potential problem relating to the software that may result in patient mix-up. This issue could affect the accuracy of patient data associated with test results.

The recall covers two software versions distributed in the United States, specifically in the states of Georgia and Wisconsin. Users of the affected software should contact Radiometer Medical ApS for further instructions on how to resolve the issue.

The recalled product

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…
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Software
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Version 2.3.0 and 2.3.1

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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