Sysmex XN-9000 Automated Haematology System. An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2017-RN-00089-1

Class II

2017-01-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00089-1

A remote possibility exists of incorrect allocation of customer demographic information against a sample in a specific situation. in a situation where the patient demographic information for a sample is not entered at the host computer and if the sample position is manually changed after being read by the barcode terminal, the customer demographics may be incorrectly allocated to the wrong patient results. one complaint worldwide has been received for this issue and in this instance, the user was not following the instructions for use, which clearly indicate that tubes should neither be removed nor inserted from the tube rack after a sample processing run has started. however, a software issue has also been identified with this system.

Sysmex is preparing a software patch for mandatory upgrade, which Roche Diagnostics’ personnel will install on the affected systems (software expected by end January 2017). Roche Diagnostics Australia will contact customers to arrange the install. In the interim, users are to ensure that: - They do not remove a rack in transit, or insert a rack or sample in anything other than the feeder when analysis is in progress; - If a STAT sample needs to be processed, they perform a manual analysis or off-line analysis; - If any sample results are sent to “Pending”, they perform a delta check; - Patient information is entered at the host computer and use both sample and patient ID. This action has been closed-out on 01/03/2018.