BD MAX System Software Version 4.44A 의 안전성 경고

Safety alert

2015-08-05

2015-08-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20150805.html

Medical device safety alert: bd max system software version 4.44a medical device manufacturer, bd, has issued a medical device safety alert concerning its bd max system software version 4.44a [serial number: ct0583]. the manufacturer has determined that bd max system software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (osr) customers utilizing user defined protocol (udp) assays. affected users utilizing only ivd assays are not affected. this anomaly may cause the osr customer system to incorrectly switch the columns of the truth table on the user’s display. if the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. the manufacturer is currently developing and validating an update to the software to correct this issue. the new software will be available by the end of august 2015. until the software can be updated on the affected instrument, users are reminded to follow osr workflow instructions to ensure that the above-described situation does not occur. no action is required for ivd assay users. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 05 august 2015.