| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00394-1 |
| Product Name/Description |
COBAS PCR MEDIA DUAL SWAB KIT. An in vitro diagnostic medical device (IVD)
Material number: 07958021190
Lot numbers: 65439501, 66393401, 66393701, 66603501
Expiry date: 31 May 2024
Instrument/Systems: cobas 4800 system, cobas 5800 System, cobas 6800 System, cobas 8800 System
ARTG 173919
(Roche Diagnostics Australia Pty Limited - Specimen receptacle IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
A higher than expected number of complaints have reported leaking COBAS PCR Media Tubes in various lots of COBAS PCR Media Dual Swab Sample Kits. The leakage can result in visible crystallisation near the cap closures and/or droplets within the packaging. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to discontinue use and discard of affected lots 65439501, 66393401, 66393701 and 66603501.
Reimbursement or replacement will be provided.
This action has been closed out on 13/08/2024 |
| Contact Information |
1800 645 619 - Nina Clifford |