| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00030-1 |
| Product Name/Description |
Elecsys HIV combi PT assay. An in vitro diagnostic medical device (IVD)
Lot numbers: 171983, 172659, 173326, 175019, 175493, 175494 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
Recent cases have been reported of a calibration signal shift regarding the Elecsys HIV combi PT assay (GMMI kit: 05390095-190) on MODULAR ANALYTICS E170, cobas e 601 and e 602 analysers.
The reagent packs reporting a calibration signal shift are affected during their use on the instrument. The affected on-board rack packs are identified by the HIV control level 1 (PC HIV level 1) recovering out of range (>3SD) during use. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche Diagnostics is recommending that if users are affected to not re-calibrate the rack pack, discontinue use of the affected pack, record rack pack details of QC and Calibration signals and use a fresh rack-pack with new calibration and follow the instructions given in the package insert. Discarded kits will be replaced by Roche Diagnostics. Roche Diagnostics are continuing to investigate the cause of the issue and will advise users when further information is available. This action has been closed-out on 29/01/2016. |
| Contact Information |
02 9860 2375 - Roche Diagnostics Australia |