Radiometer AQURE basic system software recall for patient data mix-up risk
Radiometer Medical ApS is recalling AQURE basic system software versions 2.3.5 and below due to a potential patient data mix-up risk when connected to third-party devices.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the error may lead to 'serious adverse health consequences for the patient,' which aligns with the rubric criterion for a score of 4 (Severe) involving significant injury or serious health risks.
Plain-English summary
Radiometer Medical ApS is recalling the AQURE basic system, FLEXLINK, REF 933-599, software versions 2.3.5 and below. The recall involves 947 units distributed nationwide in the United States and in various international countries, including Australia, Canada, and the United Kingdom.
The recall was initiated because the firm identified a potential problem with the blood gas and immunoassay analyzer systems that may result in patient mix-up when connected to certain third-party devices. This error could lead to serious adverse health consequences for patients due to the mix-up of patient data.
Healthcare facilities and users of the affected software should contact Radiometer Medical ApS for instructions on how to resolve the issue. The product is intended to manage analytical devices and operator profiles, and the recall is limited to the specific software versions mentioned.
The recalled product
- Product
- AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
- Manufacturer
- Radiometer Medical ApS
- Affected units
- 947
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software version 2.3.5 and below
Distribution
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