Product defect correction: Fanttest COVID-19 / Influenza A&B Antigen Test Kit - potential for control line variability
Product Defect Correction: The companies supplying Fanttest COVID-19 test kits were made aware of the potential for variability in the way the control line appears (ie a weak/faint/pale control line) when strong COVID-19 positive results are obtained. This may confuse end users in thinking that their test result is invalid while they are actually testing strongly positive for COVID-19.
This relates to all batches of:
ARTG | Sponsor |
|---|---|
414738 | Australia Health Products Central Pty Ltd (AHPC) |
395590 | Sonictec Healthcare |
What is the problem?
The Instructions for Use (IFU) state that a valid result occurs when a coloured line appears in the control region (C). There is no mention that there is potential for variability in the appearance of the control line. However, where strong COVID-19 positive results are obtained there is potential for a faintly appearing control line. This has caused customer confusion and possible misinterpretation that the test result is invalid when it is actually a valid positive result.
The manufacturer has updated the IFU for batches manufactured after February 2024 to include information about this variability or faint appearance of the control line.
What should I do?
If you encounter this when using the test kit, please regard the weak/faint/pale C line as confirming a valid result.
For further information you can contact the supplier, whose details are on the IFU leaflet, on the numbers below:
- (02) 8054 5535 - AHPC
- (02) 8328 1008 - Sonictec Healthcare
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
We cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.