Reported Feb 5, 2020 · Terminated
AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use:…
Radiometer Medical ApS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Radiometer Medical ApS · Akandevej 21 · Bronshoj, N/A · N/A
Is this the product you have?
- AQURE basic sytem, FLEXLINK, REF 933-599
- Version2.3.3 (17), CE IVD, Rx Only
- UDI(01)05700699335999
- Intended useThe AQURE system is intended to let you manage analytical devices and operator profiles
- Lot codes and dates
- Software version 2.3.5 and below
- Amount recalled
- 947
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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