| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00109-1 |
| Product Name/Description |
Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
Catalogue Number: RE52611
Lot Numbers: ECO142, ECO143
Expiry Dates: ECO142: 2018-02-28; ECO143: 2018-12-31
ARTG Number: 210636
(Abacus ALS - Clinical chemistry hormone IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, IBL has detected an issue that indicates a degradation in performance of the kit resulting in elevated cortisol values. When testing patient samples with one of the affected lots, the controls and calibrator values will meet specifications; however, due to a degradation in the starting concentration of the calibration standards, the calculated results for individual patient samples may be higher compared to LC-MS/MS measurements and may trigger unnecessary additional testing.
A review of additional data comparing the respective kit standards of the lots to LC-MS/MS data it is evident that the lots ECO142 to ECO143 generate elevated results:
- ECO142 (passing Bablok fit (y=0.009988 + 1.549X)
- ECO143 (passing Bablok fit (y=0.003142 + 1.623X)
There has not been any reports of injuries associated with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abacus is advising users to inspect stock and quarantine any remaining stock of the affected batches. Affected product will be replaced with unaffected stock.
A review of previously generated patient results is at the discretion of the Laboratory Director.
This action has been closed out on the 29/10/2018. |
| Contact Information |
1800 222 287 - Customer Service Support |