| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00945-1 |
| Product Name/Description |
Cytocell 20pter Subtelomere Specific Probe. An in vitro diagnostic medical device (IVD)
Lot number: 086784
ARTG 248555
(Sysmex Australia Pty Ltd - Human genetics-related IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
During manufacture of one batch of 20pter Subtelomere Probe, 20q DNA has been used instead of 20p DNA.
Consequently, the probe therefore hybridises to the 20q arm of chromosome 20 rather than 20p as per the device specifications and this is what users will observe with the FITC filter under a microscope.
This issue may lead to an incorrect result or a delay in results being reported.
Nevertheless, Fluorescence in situ hybridisation (FISH) tests would be used only as an adjunct to other diagnostic laboratory tests, and therapeutic action would not be initiated on the FISH result alone.
There have not been any adverse health consequences related to this defect to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to inspect stock immediately and quarantine affected stock of Lot 086784 on hand to prevent further use.
Laboratories are to undertake a review of the results obtained with the affected devices and check that no incorrect results were reported due to the product not performing as intended.
Sysmex Australia Pty Ltd will arrange for return of the affected goods and organise a replacement via the overseas manufacturer as no alternative stock is currently held in Australia.
This action has been closed out on 31/01/2024 |
| Contact Information |
0423 841 878 - Hannah-Rose Martin |