Z-1394-2023Class II

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...

Name: Z-1394-2023 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...
Creator: Radiometer Medical ApS
Published: 2023-03-08
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2023-03-08 / Open, Classified / root cause: software

FDA source

Radiometer Medical ApS began a recall of 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... on 2023-03-08. FDA classified it as Class II and gives the reason as "Due to potential software issue that may result in patient mix-up information". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1394-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-08
Posted: 2023-04-17
Recalling firm: Radiometer Medical ApS
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 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 code: OUG Medical Device Data System
Reason for recall: Due to potential software issue that may result in patient mix-up information.
Root cause tag: software
FDA root cause: Software design
Action: On 03/08/2023, the firm sent an "Urgent: Medical Device Recall" letter via email and FedEx to customers informing them that there is a potential software issue that may result in patient information mix-up when connected to the LumiraDx device. This may potentially result in a patient with critically or life-threatening elevated levels of D-dimer or NT-pro-BNP being diagnosed with levels within the normal range. Customers are instructed to perform: 1) With immediate effect, cease using the LumiraDx devices if connected with an AQURE system with the affected software versions: 2.5.2, 2.5.3, 2.5.4 2.6.0 2.6.1 2) Within two weeks of receipt of this letter, complete and email a copy of the Recall Response Form and return it to a Radiometer Representative. A Radiometer Representative will contact and schedule a visit or remote session to: " If you use LumiraDx devices connected with AQURE, your AQURE system must be upgraded. Your local Radiometer representative will contact you when a solution is available. " If you do not use LumiraDx devices, your Radiometer representative will contact you and remove the LumiraDx driver from the AQURE system, hence preventing the usage of LumiraDx devices in context with your current AQURE system(s). For questions, contact Radiometer at 1-800-736-0600, Monday - Friday 9 am to 7 pm (EST).
Quantity in commerce: 1,806 systems
Distribution: Worldwide - U.S. Nationwide including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Brazil, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.
Product codes and lots: Model Number: 933-599 UDI-DI Code: 05700699335999 Software Versions: 2.5.2 and above (Versions 2.5.2, 2.5.3, 2.5.4, 2.60, and 2.6.1)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1394-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1394-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-17

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)