VITROS Automation Solutions configured with a Thermo Scientific Centrifuge Module. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01254-1

Class I

2016-09-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01254-1

Ortho has become aware that there is the potential for test results to be mis-associated with the wrong sample id (sid) and to be reported prior to the tcautomation system detecting a sid mismatch. this mis-match may occur when the centrifuge module fails to grip the sample tube when attempting to unload the centrifuge.The system will generate an error message for the unload failure, however the centrifuge will continue to operate as normal. the sample rack containing the sample that has not been unloaded will be transferred back to the load side of the centrifuge, and the system will not recognise that the sample is still in the rack. this may result in the sample being re-analysed and the sid being mis-associated. assay results are potentially associated with the wrong patient and may be reported. this could lead to misdiagnosis or inappropriate treatment of a patient. ortho received no reports of patient injury due to this issue.

Ortho is advising users to check samples associated with Cross Check errors when they appear on the TAC error messages screen, and to ensure preventative maintenance and cleaning procedures for the centrifuge are carried out as required. Past occurrences of this issue are not easily identifiable, and a review of previous results may be impractical. Ortho is recommending users discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 18/05/2017.