Radiometer ABL700 and ABL800 series blood gas analysers. An in vitro diagnostic medical device (IVD). Radiometer pH electrode, 945-614 with pCO2 membrane, 942-063 (D788) 의 리콜

Recall

RC-2016-RN-01538-1

Class II

2016-12-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01538-1

In july 2013 customers were informed about the possible risk of negative bias on some pco2 results on both blood and qc measurements. as a temporary countermeasure, users were required to manually narrow the qc ranges for pco2 and also perform extra qc measurements when replacing the membrane. the root cause investigation for the pco2 issue revealed a problem with gas leak at the ph electrode. in nov. 2014 a new improved blue sealing ring for the ph electrode was released. radiometer advised that the temporary countermeasure with the qc could be revoked upon installation of the improved sealing ring. further investigation has identified that over time, the dimensions of some of these new blue sealing rings changed. the blue sealing ring was improved and the updated version released in dec. 2015. tests were performed to monitor their performance over time and have shown that the dimensions of the updated sealing rings do not alter. these blue sealing rings are to be installed.

Radiometer will replace the current sealing ring at the Planned Maintenance for the analyser(s) within the next 12 months. If users are experiencing any problems with pCO2 results, they are to contact their Radiometer representative to arrange an earlier time for the replacement of the sealing ring for the pH electrode. When the sealing ring is updated Radiometer will also replace any stock currently held of the 834-682 sealing ring. A Service report will be provided when the sealing ring is replaced.