BD MAX Instruments. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2013-RN-00582-2

Class II

2013-06-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00582-2

Bd has determined during instrument testing a small portion of instruments were built with the wrong power module component, which is rated 1 amp instead of the required 10 amp. bd has advised that the user would not be aware of this defect, as the instrument will function as expected, with no impact on specimen processing or results reporting. however, the component inside the instrument will get hot, and over time the component will fail, which could cause downtime and require a service visit.The bd max instrument operates with a current between 1.3 and 3 amps. in assessing the potential impact of installing a 1 versus 10 amp power input module, the manufacturer ran the 1 amp power input module at various current levels and measured the temperature of the component, with the following results:1.9 a for 14 minutes – 45°c3.3 a for 20 minutes – 66°c4.4 a for 14 minutes – 80°c. the component is rated by its manufacturer for use up to 85°c.

A BD service representative will correct affected systems on-site after undertaking a system check to determine if there are any affected systems in the field.