DxH 500 Haematology Analyser, with software version 1.0.2. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00705-1

Class II

2017-05-30

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00705-1

Beckman coulter has become aware that when the instrument temperature (<18°c to >36.5°c) is exceeded, the dxh 500 allows sample processing and result reporting despite the instructions for use (table 10.4) stating that “the run sample is inaccessible”. results generated in this scenario may be erroneous. additionally:- the message on the results screen/printout reads “instrument temperature” instead of “instrument temperature out of range”- the results are transmitted to the laboratory information system (lis) without the accompanying “instrument temperature out of range” message. using the auto-transmit option could lead to the release of erroneous results to the lis.If the instrument is operating out of the temperature range, the warnings on the screen are ignored and the results used, then:- these cbc, wbc-diff or cbc/wbc-diff results may be erroneous.- if these erroneous results are released to the physician, this could result in inappropriate patient management.

Beckman will be correcting the issue in a future software update. In the interim, the following instructions are provided to users: - When the message “Instrument Temperature Out of Range” or “Instrument Temperature” is displayed on the system or printouts, do not report the patient results. - Ensure the laboratory ambient temperature is within specifications (18°C - 32°C) when processing samples. - Disable the auto-transmit option if there is a potential for the operational temperature to be exceeded. - Consult with your Medical Director to determine if a retrospective review of results is warranted.