The State medical products regulator has advised retailers to stop selling one of the most commonly used antigen tests.
The Genrui SARS-CoV-2 Rapid Antigen Self-Test was on sale in several large retailers and supermarkets, including Lidl and Dunnes.
In a statement this evening, the Health Products Regulatory Authority (HPRA) said it had received over 550 reports of the test returning false-positive results.
It comes after widespread criticism of the brand on social media.
Received 100s of messages through my Insta about Genrui antigen tests.
When pcr was available there seemed to have been lots of false positives with these kits.
This could have major implications for people now with no pcr available.
Have you had any issues with them? pic.twitter.com/hmMgGz8hFp
— Dr Niamh Ni Loinsigh (@niamh_dr) January 1, 2022
The HPRA said all rapid antigen tests can potentially return false positives or negatives but noted that the rapid rise in the number of reports of false-positive results relating to the Genrui self-test was “significant”.
It said the product should be removed from shelves as a precaution while the matter is further investigated by the manufacturer.
The regulator is also urging people not to purchase the tests online while the investigation is ongoing.
It noted that anyone who has received a positive result from any rapid antigen self-test including Genrui should continue to follow the current public health advice on the HSE website.
Anyone who has experienced a false positive or a false negative can report it to the HPRA here.