| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01084-1 |
| Product Name/Description |
QMS Everolimus Immunoassay (used for the therapeutic monitoring of immunosuppressant drugs). An in vitro diagnostic medical device (IVD)
Catalogue Number: 0373852
Lot Number: 72258007
Expiry Date: 31 July 2017
ARTG Number 235822 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has determined that the affected lot may yield over-quantitation in patient samples.
The manufacturer has conducted an internal assessment of product performance, and determined that over-recovery of whole blood assay results in the sub-therapeutic range by as much as 50% (for example, a reported assay result of 3.75 ng/mL instead of the actual whole blood concentration of 2.5 ng/mL). Given standardised medication toxicity and close monitoring of patients for markers of efficacy, the risk of developing serious or long-range adverse health consequences due to a single reported erroneous everolimus concentration result is deemed to be negligible. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermofisher is advising users to discontinue use and destroy any remaining stocks of the affected batch. A credit note will be issued for the affected product. A review of previously generated results should be considered by the laboratory director and treating physician.
This action has been closed out on 7/09/2018. |
| Contact Information |
02 8817 4279 - Thermo Fisher Scientific |