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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00752-1
Product Name/Description	Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests 240 tests Part Numbers: 05235901190 Lot Numbers: R15771 960 tests Part Numbers: 05235910190 Lot Numbers: R15304
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	23/07/2013
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	During an internal investigation, a formulation error was identified during the manufacture of the cobas 4800 HPV Master Mix reagent leading to an increased rate of invalid runs. This issue does not cause incorrect specimen results, however results from failed runs must be repeated.
Recall Action	Recall
Recall Action Instructions	Roche is requesting users to discontinue use and discard all units from the affected lots. Roche will replace any affected units.
Contact Information	1800 645 619 - Roche Diagnostics Technical Support