| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00152-1 |
| Product Name/Description |
Fanttest COVID-19/lnfluenza A&B Antigen Test Kit. An in vitro diagnostic medical device (IVD)
Product Code: ICF-535
Batch Numbers: I2401007, I2401008
Expiry Date: Feb 2025
ARTG 414738
(Australia Health Products Central Pty Ltd - Multiple-viruses IVDs) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
AHPC has been made aware there is potential for variability in the control line - A weak/faint/pale C(control) line could be observed in some cases where strong COVID-19 positive results are obtained.
A weak C(control) line may cause confusion and make consumers regard the result as invalid while they are actually testing strong positive for COVID-19.
The manufacturer has updated the instructions for use for batches manufactured after February 2024 to include information about variability in the control line. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should regard the weak/faint/pale C line as a valid result and can request alternative goods from their supplier if they are concerned. |
| Contact Information |
02 80545535 |