| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00962-1 |
| Product Name/Description |
Serology ToRCH IgM Positive Control. An in vitro diagnostic medical device (IVD)
Catalogue number: SR10349
Lot number: 157SR
Expiry: 28/05/2024
ARTG 354723
(Randox Australia Pty Ltd - Multiple infectious organism IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
Randox Laboratories can confirm there has been a decrease in the reactivity of HSV Type 1/2 IgM in the Serology ToRCH IgM Positive Control, SR10349, lot 157SR when tested on the DiaSorin Liaison XL.
Randox Laboratories also confirm there has been a Transcription error on the instructions of use (IFU) for SR10349 lot 216SR. The method for Toxo IgM has been listed as 'Reactive' rather than 'Biomerieux Vidas'. The method for HSV Type 1/2 IgM was listed as 'Biomerieux Vidas' rather than 'DiaSorin Liaison XL'. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
For issue 1, Randox note that while still testing positive for HSV Type 1/2 IgM, they advise that all customers cease the usage of the control for this marker as a precaution. The other markers within this lot are not affected.
Customers should discard all copies of the IFU they currently have and download the latest version from www.randox.com.
Customers should discuss the contents of the custoemr letter with their Medical Director. |
| Contact Information |
technical.services@randox.com |