AU680 chemistry analysers with software version 4.05. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01426-1

Class II

2016-11-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01426-1

Beckman coulter has identified two issues occurring on au680 analysers installed with software version 4.05 that may cause a delay in reporting test results.Issue 1: only occurs with non-beckman coulter reagents. the “(” flag, which indicates a shortage of cleaning solution for contamination parameters, is unintentionally attached to test results depending on specific programming in the contamination parameters screen. there is no impact to test results, however the unintentional “(” flag may cause confusion regarding the volume of cleaning solution and unnecessary concern regarding potential carry-over.Issue 2: sample blank tests (total bilirubin and direct bilirubin) included in a qc profile are not analysed when requisitioned from the stat status > qc screen and run on the stat table. no qc results are initially generated for sample blank tests (total bilirubin and direct bilirubin). however, re-running the tests individually will generate the appropriate test results.

Beckman Coulter is providing temporary workarounds in the customer letter, in the form of step-by-step instructions to prevent each software issue. Beckman Coulter will resolve these issues in the next release of the AU680 software.