| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00012-1 |
| Product Name/Description |
Fanttest COVID-19/Influenza A&B Antigen Test Kit. An in vitro diagnostic medical device (IVD).
Product Identifiers: I2210004 to I2210006, I2212002 to I2212006 and all batches after.
Expiry Date: 09/2023 to 05/2025
ARTG 395590
(Sonictec Pty Ltd - Multiple-viruses IVDs) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
Sonictec has received an increasing number of customer complaints reporting a faint/pale C (control) line and strong T (test) line for the Covid-19 test, leading to customer confusion about the validity of the result.
The manufacturer’s investigation has determined that there is potential for variability in the control line - A weak/faint/pale C 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.
This action supersedes the quarantine issued in January 2024. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Please note that stock that was quarantined can now be used providing suppliers and pharmacists explain the potential weak C line issue to customers before supplying the product.
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 8328 1008 - Sonictec |