Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD)(used with cobas c 501 and c502 modules) 의 리콜

Recall

RC-2017-RN-00902-1

Class II

2017-07-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00902-1

When the incubation bath is cleaned or cuvettes replaced on the cobas c 501/502 modules during routine monthly maintenance, the usm cover 3 is removed. whilst loosening one of the thumb screws on this cover, an instrument operator cut their thumb on the 90-degree edge of the thumb screw bracket.Given the cobas c 501 modules and cobas c 502 modules share the same hardware, roche diagnostics has, as a precaution, decided to inform and request operators of both systems to perform the related maintenance task with special caution, to prevent any further occurrence.Although the design of the usm cover 3 is according to the manufacturer’s specification, and the 90-degree edge is clearly visible, a medical risk due to an injury cannot be entirely excluded. roche has received only one complaint since this product was launched in 2006. a warning statement will be added to the respective operator manuals specifying the need to perform the related maintenance task with special caution.

Roche Diagnostics will add a warning statement to the respective operator manuals, which will be available by December 2017.