| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00543-1 |
| Product Name/Description |
EndoPredict QS Kit Part 2 of 5: Optical Sealing Foil. An in vitro diagnostic medical device (IVD)
REF: SV33F
Lot: OF10022 & OF10024
Expiry: 31.05.2025
ARTG 285557
(Myriad Genetics Pty Ltd - Acquired genetic alteration IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
A production problem appears to have kinked some of the Optical Sealing Foils provided as part of the Endopredict IVD.
The kinked foil can affect the RT-qPCR measurement and while usually leading to an invalid result, it is not impossible that the system will produce a result, which may lead to the patient being prescribed a less than optimum therapy regime. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers:
1. Should Check not yet used Optical Sealing Foils for kinks. Damaged Optical Sealing Foils must not be used for
a measurement and should be disposed of according to local regulations.
2. Can request replacement for damaged Optical Sealing Foils through the appropriate customer support via e-mail to
epsupport@myriadgenetics.eu.
3. In case there is any doubt that patient samples were analysed with damaged Optical Sealing Foils, it is recommend repeating the analysis with existing FFPE samples.
This action has been finalised on 17/7/2024. |
| Contact Information |
epsupport@myriadgenetics.eu - Myriad Genetics |