Radiometer recalls AQURE basic system (version 2.3.3) due to potential patient data mix-up with third-party devices, risking serious health consequences. Affected units have specific UDI codes.
The firm has become aware that there is a potential problem relating to the blood gas and immunoassay analyzer Systems that may result in patient mix-up when connected to some third-party devices. The error may lead to serious adverse health consequences for the patient caused by patient data mix-up.
Radiometer is recalling its AQURE basic system (version 2.3.3) because it may mix up patient data when connected to some third-party devices, which could cause serious health issues. This affects medical devices used in clinical settings for blood gas and immunoassay testing.
The system may mix up patient data when connected to certain third-party devices. This error could lead to serious health consequences if the wrong patient data is used for treatment decisions.
Healthcare providers using the AQURE basic system for blood gas and immunoassay testing are most at risk. Patients receiving care through this system could be affected if data mix-up occurs.
Check for the model name 'AQURE basic system', version 2.3.3 (17), and the UDI code (01)05700699335999. The device is intended for clinical use in blood gas and immunoassay testing.
Verify the software version is 2.3.3 (17) or lower by checking the device's label or documentation.
Reach out to Radiometer Medical ApS for guidance on potential risks and next steps if you have the affected device.
The recalled model is the AQURE basic system with version 2.3.3 (17), UDI code (01)05700699335999.
Yes, the recall states that patient data mix-up could lead to serious health consequences if the wrong patient data is used for treatment.
No, the recall does not require immediate stop-use. Healthcare providers should check the device version and contact Radiometer for guidance.
We’ve drafted a message you can send Radiometer to request your refund or repair — edit it as you like.
Subject: Recall Z-0864-2020 — Radiometer Radiometer Hello, I own a Radiometer that is covered by recall Z-0864-2020 from Radiometer. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
