AQURE Data Management System Software prior to version 1.8.2 may be affected. 의 리콜

Recall

RC-2014-RN-00453-1

Class II

2014-04-17

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00453-1

Radiometer has recently become aware of three potential issues with unit conversion in aqure that may occur if the device is transmitting in a different unit than aqure is displaying and/or transmitting to the his/lis. - conversion of ketone from mmol/l to mg/dl or vice versa: the parameter ketone is measured on either the siemens clinitek or the docureader. this is not applicable in australia as none of these devices are connected to aqure. - conversion of glucose and lactate from g/l to mmol/l or vice versa: in both cases a potential wrong conversion factor may be used, which may cause the reported result to be incorrect by a factor 10,000. this problem may be present in all versions of aqure.- converting from mg/dl to mg/l and g/dl to g/l or vice versa: a potential wrong conversion factor may be used of 1/10. the correct factor is 10. reported results may be incorrect by a factor 100. this problem is not parameter specific and may be present in all versions of aqure.

End users are requested to not change the units on AQURE or iSTAT without consulting Radiometer Pacific. Radiometer will be carrying out testing to identify affected software and a software update will be installed to correct the issue. This action has been closed-out on 29/01/2016.