Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-01072-1

Class II

2017-08-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01072-1

An error handling issue for code 7-101, liquid sensor error, has been reported on the phadia 1000 instrument. when error 7-101 occurs, immunocap dispensing will stop, whereas already dispensed samples will continue to be processed. due to an isw issue, the “retry” command, used to clear this error, does not function properly and there will be no further pumping of wash and rinse solution during the processing of the dispensed samples.Thus, if the error code 7-101occurs during the assay run, there may be a shortage of wash and rinse solution that will affect assay performance and test results if the operator chooses to respond to the error with the “retry” command.

A mandatory ISW update will be provided to correct the problem. In the meantime, Abacus ALS advise you to take the following actions: - All instrument operators are to be instructed that if the 7-101 error occurs during an assay run, the “Stop” command must be selected. This will abort the run and results flagged as erroneous. Results from the assay run should not be approved. - Review records to determine if error 7-101 has occurred. If the instrument error message “7-101 LIQIUD SENSOR ERROR (Wash upper ON lower OFF)” has been reported. Abacus ALS will be contacting you to assist with this. - Fill in and return the supplied acknowledgement form - Phadia AB will have a revision of the current ISW version available soon. Technical Support staff will contact users in regards to the scheduling of this mandatory software installation.