| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00277-1 |
| Product Name/Description |
Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical device (IVD)
CTNI Sample Diluent
Catalogue Number: KD692
Siemens Material Number: 10445202
Lot Number: 7BDA34
Expiry Date: 01-06-2018
Multi 2 Sample Diluent
Catalogue Number: KD694
Siemens Material Number: 10483586
Lot Number: 7CDA79, 7DDA70
Expiry Date: 01-09-2018, 01-11-2018
ARTG Numbers: 182774 and 182222
(Siemens Healthcare - Troponin IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that some Dimension Vista Diluent lots may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the Dimension Vista System, due to a reduced volume of diluent being pipetted from the vial.
There have been no injuries reported as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising users to inspect stock and discard any remaining stock of the affected lots.
Siemens is not recommending a review of previously generated results.
This action has been closed out on 25/02/2019 |
| Contact Information |
1800 310 300 - Siemens Customer Service Support |