CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report

Aqure REF 933-599 Software Versions 2.5.2 recalled

Radiometer Medical ApS is recalling Aqure REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The, distributed nationwide in the US. The recall was initiated on 8 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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)

Quantity recalled1,806 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1394-2023
FDA event ID: 91917
Recalling firm: Radiometer Medical ApS, Bronshoj, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 8 Mar 2023
FDA classified: 17 Apr 2023
Reported: 26 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Medical Software

Timeline

8 Mar 2023	Recall initiated by company
17 Apr 2023	Classified by FDA	+40 days
26 Apr 2023	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to potential software issue that may result in patient mix-up information.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Montana

Questions about this recall

Is Aqure REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The recalled?

Yes. Radiometer Medical ApS recalled Aqure REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The on 8 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1394-2023.

Why was it recalled?

Due to potential software issue that may result in patient mix-up information.

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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