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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01363-1
Product Name/Description	cobas 4800 PCR Media Kit, cobas 4800 PCR Urine Sample Kit and cobas PCR Female Swab Kit. An in vitro diagnostic medical device (IVD) Part Numbers/lot numbers: 05170486190/S01885 & earlier (except S01884) and 05170516190/S10487 & earlier
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/12/2013
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	Roche Diagnostics Australia would like to inform users of the possibility of leakage occurring for some batches of cobas® PCR media IVD. These are packaged into different lots via the cobas PCR Urine IVD Kits and cobas PCR Female Swab IVD Kits.
Recall Action	Recall for Product Correction
Recall Action Instructions	Roche is requesting their customers to continue to follow the instructions for use and to inspect each tube or blister pack for evidence of leakage. If leakage is detected the media must be discarded.
Contact Information	02 9860 2329 - Roche Diagnostics Australia