Recall Z-0864-2020— Radiometer Medical ApS
Class II · Terminated
Class II FDA medical device recall by Radiometer Medical ApS, initiated 2019-08-08, terminated 2022-06-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Radiometer Medical ApS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-08
- Terminated
- 2022-06-06
- Firm location
- Bronshoj, N/A, Denmark
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.