| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00373-1 |
| Product Name/Description |
cobas 8100 BRF and URF with software versions 02-xx. An in vitro diagnostic medical device (IVD)
cobas 8100 automated workflow series
BRF for cobas 8100
Material Number: 07439954001
URF for cobas 8100
Material Number: 07441657001
ARTG Number: 173887 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue regarding the reformatter modules URF and BRF of the cobas 8100 automated workflow series (when used with software version 02-xx) has been identified. This issue is caused by an incorrect mechanical control sequence based on a limitation in software versions 02-xx, resulting in the racks to be shaken and specimen spillage. Sample spillage may cause cross contamination of samples and potentially expose operators to infectious material. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Until the installation of the software upgrade, Roche Diagnostics is advising users to ensure that the rack buffering function is disabled in the configuration of the Control Unit. In the event of a major spillage, users are advised to set the affected modules offline. These modules should be checked and cleaned by a Roche Service Representative before being returned to routine operation.
This action has been closed-out on 15/03/2018. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |