| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00853-1 |
| Product Name/Description |
Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)
cobas e 601 module
Material Number: 04745922001
cobas e 602 module
Material Number: 05990378001
MODULAR ANALYTICS analyser
Material Number: 03617505001
MODULAR ANALYTICS EVO analyser
Material Number: 04998642001
All software versions
ARTG Number: 173887 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Roche has identified that in very rare cases a sample mismatch may occur in specific immunochemistry modules. This issue can only occur if all 5 conditions below are met simultaneously.
1. The immunochemistry module is included in its respective system (not standalone); and
2. The “Module Rack Buffer setting” ? 1; and
3. One rack (Rack A) is undergoing sampling and the following rack (Rack B) is waiting for measurement; and
4. The Gripper (T/V Carrier) fails to pick up the last vessel on Rack A. As a result, the measurement for the sample in the last vessel which failed to be picked up is cancelled and the warning “Tips/Cup pick up error” (Caution Level) is issued; and
5. Sample position 1 of the following rack (Rack B) is empty or has no test order for the immunochemistry module.
This issue may be detected by 2 alarms occurring within a few minutes of one another:
“Tip/Cup pick up error” (Caution Level)
“Abnormal L2-line Movement” (S.Stop Level) |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche Diagnostics is requesting customers follow the detailed instructions given in the Customer Letter and to acknowledge receipt of the communication even if they have no stock which is subject to this recall action.
This action has been closed out on 18/10/2019 |
| Contact Information |
02 9860 2357 - Roche Diagnostics |