| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00356-1 |
| Product Name/Description |
cobas MPX test. An in vitro diagnostic medical device (IVD).
Material Number: 06997708190 (96 tests)
Lot Numbers: 242567 and 267989
ARTG Number: 275469
(Roche Diagnostics Australia - cobas MPX. - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Globally, Roche has received a number of customer reports of selected lots of the cobas MPX test generating unexpected initial false reactive results, which do not match the serology profile of the sample.
Roche Diagnostics Australia has received no reports of false reactive results with the affected lot numbers from Australian customers. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is requesting users to discontinue use of and discard any remaining inventory of the affected lots, on receipt of replacement unaffected stock. A Roche Diagnostics Australia representative will be in touch with any affected customers to arrange replacement stock.
This action has been closed out on 05/07/2019 |
| Contact Information |
02 9860 2357 - Roche Diagnostics |