Radiometer recalls AQURE software versions 2.3.0 and 2.3.1 due to potential patient mix-up. Affected healthcare facilities should update software to prevent misidentification of patient data.
There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
Take action
Contact the company
📍Recalling firmRadiometer Medical ApSAkandevej 21 · Bronshoj, Denmark
✎ GovInfoNow plain-language explainer
Radiometer is recalling software versions 2.3.0 and 2.3.1 for the AQURE system. This update could cause patient data mix-ups, which might lead to incorrect test results or patient misidentification in healthcare settings. Read more at govinfonow.com/recall/71859-radiometer-aqure-software-2-3-0-2-3-1-patient.
“Radiometer AQURE Software 2.3.0/2.3.1: Patient Mix-Up Risk.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71859-radiometer-aqure-software-2-3-0-2-3-1-patient. Based on FDA recall #Z-1582-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1582-2018%22&limit=1).
The FDA announced on Feb. 27, 2018, that Radiometer Medical ApS voluntarily recalled the AQURE system software versions 2.3.0 and 2.3.1 due to a potential patient mix-up hazard. The agency classified the recall as Class II.
How to tell if you have it
Brand: Radiometer
Product: AQURE System, Software version 2.3.0 and 2.3.1
Units affected: 2
The hazard
According to the FDA, there is a potential problem with the AQURE System versions 2.3.0 and 2.3.1 that may result in patient mix-up.
Context
GovInfoNow's records show Radiometer Medical ApS has 16 other recalls on record since Aug. 8, 2019. Other recent recalls of similar products include Radiometer AQURE System Software Versions 2.5.2-2.6.1 May Cause Patient Data Mix-Up (March 8, 2023), Nova Biomedical StatStrip Glucose Meter System Recall: Patient Data Mix-Up Risk (July 29, 2026) and Nova Biomedical StatStrip Glucose Meter Software Issue: Patient Data Mismatch Risk (July 29, 2026).
How to tell if you have this one
Check if your AQURE system has software versions 2.3.0 or 2.3.1. The product is used for professional healthcare settings to manage patient data and test results.
Brand
Radiometer
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Radiometer will provide updated software versions to fix patient data mix-up issues.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states to Georgia and Wisconsin.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, Wisconsin.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall addresses a potential patient mix-up risk, but it does not indicate a risk of serious injury or death. The hazard is low risk as it relates to data errors rather than physical harm.
What should I do if I have the recalled software?
Radiometer will provide updated software versions to fix the patient data mix-up issue. No immediate action is required beyond updating the software.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1582-2018 (February 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1582-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.