Food, drugs, devices › Radiometer Medical ApS
Device recall: AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analy
FDA enforcement event 79411 is a device recall by Radiometer Medical ApS of Bronshoj, N/A, initiated 27 Feb 2018 and classified Class II, with 1 product record.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 20 Mar 2019. Initiation: voluntary: firm initiated. Radiometer Medical ApS has 17 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Radiometer Medical ApS, Bronshoj, N/A, Denmark.
Reason for recall
"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."
Distribution
"US Nationwide Distribution in the states to Georgia and Wisconsin."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1582-2018 | 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 connected devices at the point-of care or… | 2 | Class II | Terminated | 9 May 2018 |
Context
Other enforcement events for Radiometer Medical ApS
All 17 events for Radiometer Medical ApS
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states to Georgia and Wisconsin."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Mar 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.