The Health Products Regulatory Authority (HPRA) has called for the removal of the Genrui Covid-19 Rapid Antigen Self-Test from sale as an investigation has been launched into a number of 'false positive' results.
Based on the advice, a number of retailers have pulled the tests from sale.
This follows receipt by the HPRA of over 550 reports in recent days from Irish consumers of false positive results associated with the use of this particular antigen self-test.
A statement from the HPRA says: "Rapid antigen tests, like all diagnostic tests, have the potential to provide false negative or false positive results.
"However, the HPRA states that the rapid rise in the number of reports of false positive results relating to the Genrui self-test is significant and a precautionary removal from sale is warranted while the matter is further investigated by the manufacturer (Genrui Biotech, Shenzen, China) and its European representative. The HPRA also advises against the online purchase of Genrui self-tests at this time while the matter remains under investigation.
"Individuals who have received a positive result following use of any rapid antigen self-test, including this test, should follow the current public heath advice on the HSE website."
The HPRA say that they will continue to liaise with the manufacturer to investigate the matter further, and is also in contact with other European Competent Authorities in relation to this issue.
They add: "Individuals who have experienced a false positive or false negative result can report the occurrence via the HPRA website – www.hpra.ie
"The HPRA wishes to acknowledge the cooperation and swift response of retailers in relation to this matter. Any retailers supplying this product who have not yet received communication in respect of this issue should contact devicesafety@hpra.ie."
