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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00902-1
Product Name/Description	Ultrasonic Mixer cover (USM) 3. An in vitro diagnostic medical device (IVD) (used with cobas c 501 and c502 modules) Material Number: 05400937001 ARTG Number: 173887
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/07/2017
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	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.
Recall Action	Recall for Product Correction
Recall Action Instructions	Roche Diagnostics will add a warning statement to the respective operator manuals, which will be available by December 2017. This action has been closed out on the 12/11/2018.
Contact Information	02 9860 2357 - Roche Diagnostics