| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00138-1 |
| Product Name/Description |
CYSTATIN C CALIBRATOR and CONTROL LEVEL 2 and 3 "An in vitro diagnostic medical device (IVD)"
Multiple Product and Batch Numbers.
ARTG 199684
(Randox Australia Pty Ltd - Clinical chemistry-specific protein IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Randox Australia Pty Ltd has identified the Cystatin C Calibrator Series CYS2699 is running with a negative bias compared to other methods and requires realignment to the reference standard.
The defect has the potential to misreport patient results.
In line with the realignment to the Cystatin C Calibrator Series, Randox Australia Pty Ltd is updating the target and range for the Cystatin C controls, CYS5019 and CYS5020.
No adverse events were recorded. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to provide proof of scrappage of Cystatin C Calibrator CYS2699 and a replacement calibrator lot will be provided.
For Cystatin C controls, customers will be advised via field safety notice about the realignment.
Value sheets and IFUs will be updated and made available online. |
| Contact Information |
02 9615 4640 - Randox Australia Pty Ltd |