LAST UPDATE | 5 Jan 2022
THE HEALTH PRODUCTS Regulatory Authority (HPRA) has said that retailers are to remove the Genrui brand antigen tests from sale until further notice.
The HPRA issued the advice this evening, saying that it was based on 550 reports of false positives being reported by Irish consumers associated with the use of Genrui antigen tests.
Yesterday, The Journal reported that the HPRA were investigating the antigen tests after complaints were sent to the regulator about false positives.
In a statement this evening, the HPRA said that while all antigen tests have the possibility to give false positives and negatives, the number of false positives being reported on Genrui antigen tests is “significant”.
“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,” said a spokesperson for the HPRA.
“The HPRA also advises against the online purchase of Genrui self-tests at this time while the matter remains under investigation.”
The Genrui brand of antigen test has been sold in multiple outlets across Ireland including supermaket and convenience store chains.
The HPRA have advised that anyone who receives a positive test result from a rapid antigen test, including Genrui tests, to follow current HSE public health guidelines.
The regulator has said that it will continue to liaise with Genrui to “investigate the matter further” and that it is also in contact with European Competent Authorities on the issue.
Anyone who has received a false positive on Genrui antigen tests can report them on www.hpra.ie
A spokesperson for Lidl told The Journal that they stopped stocking Genrui antigen tests “well before Christmas”, but that they did not have information on when stores stopped selling the tests.
Consumer protection
Dermott Jewell, Policy and Council Advisor to the Consumers Association of Ireland says that the situation is an “unusual” one.
“This is an unusual one as there is a recommendation that the product be withdrawn from sale – without specific and qualified reasons for this request,” said Jewell, speaking to The Journal.
He says that as Genrui antigen tests also carry an EU CE mark, which certifies it as meeting EU standards, it makes it more unusual.
He says that as the HPRA have issued the advice, consumers should not continue to buy Genrai antigen tests anywhere else.
He also advised people if they have bought them, to return them if a product recall is announced by retailers.
“If the product is recalled, seek refund for unused supplies, pending further advice from the HPRA and other health regulators,” said Jewell.
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