| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00744-1 |
| Product Name/Description |
cobas omni MGP Reagent when used with cobas MPX assay. An in vitro diagnostic medical device (IVD)
(for use on the cobas 6800/8800 systems)
cobas omni MGP Reagent Material Number: 06997546190
Pack Size: 480 tests
Lot Numbers: W17311, X05638, X05639, X16159
ARTG Number: 175163 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics has observed an increased rate of invalid Internal Control (IC) results for cobas MPX when used with certain lots of the cobas omni MGP Reagent. This issue affects only the blood screening assays, cobas MPX. For the non-blood screening assays, these lots of cobas omni MGP Reagent continue to meet specifications, and no performance issues have been identified. The cobas 6800/8800 Systems will correctly flag a sample result as invalid if the Internal Control is invalid. There is no risk of generating incorrect patient results as a consequence of this issue. All previously generated valid results and runs remain valid. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is advising customers to restrict the use of affected cobas omni MGP Reagent lots to non-blood screening assays only (CMV; CT/NG; HPV), and discontinue the use of these specific lots with the cobas MPX.
This action has been closed out on 08/07/2019 |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |