Radiometer ABL90FLEX and ABL90FLEX PLUS Blood Gas Analyser with software version below 3.2. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01201-1

Class I

2016-09-13

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01201-1

Radiometer has recently become aware of a potential risk that the analyser may report patient results although the analyser performance has not been verified by running quality controls. ultimately, this could lead to incorrect results being reported and these results will not be flagged. in a case where the patient has abnormal values for a parameter(s), the patient may erroneously be perceived as having normal values. this may lead to wrongful diagnosis and wrongful treatment. in a worst-case scenario, the patient may be subjected to lack of critical treatment.The issue may occur if the operator manually exits the conditioning mode, which is active during the initial start-up of a new sensor cassette. if “exit conditioning” is pressed to run an urgent sample the analyser goes to “ready” with- out performing three levels of quality control, which are run upon automatic exit.The regular qc schedule, one level every eight hours, will be effective though.

Radiometer is providing users with work around instructions as an interim measure. Users are advised to avoid exiting the Conditioning Mode manually, or if an early exit is required, to manually re-run the three levels of QC before running any patient samples. Radiometer is investigating the issue and will provide an update to inform users about the long term solution which will be put in place to prevent the above situation from occurring. The long term solution is expected to be an update of the analyser software and of the Instructions for Use.