The Recall Desk
HighFDA (Devices)·Z-1394-2023·Announced 2023-04-26

Radiometer AQURE Software Recall Due to Patient Mix-up Risk

Radiometer is recalling AQURE laboratory software versions 2.5.2 through 2.6.1 due to a potential issue that could cause patient data mix-ups.

What this means for you

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: FDA Class II recall with a theoretical patient data mix-up risk in a laboratory system. Per the rubric, risk-of-harm products without reported illnesses or injuries score as High (3).

Plain-English summary

Radiometer Medical ApS is recalling the AQURE REF 933-599 laboratory information system, which includes software versions 2.5.2, 2.5.3, 2.5.4, 2.6.0, and 2.6.1. The AQURE system is designed for managing analytical devices, operator profiles, and patient data in point-of-care and laboratory settings. Approximately 1,806 systems have been distributed worldwide, including throughout all U.S. states and more than 50 countries.

The recall is due to a potential software issue that may result in patient mix-up information. This means that patient data could be incorrectly associated with test results or other records within the system.

The recalled product

Product
AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 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 co
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Laboratory Information System
Hazard
  • patient-data-mixup
  • software-defect

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 (4)

  • 2.5.3
  • 2.5.4
  • 2.60
  • and 2.6.1)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category