Retailers are being asked to remove Genrui-branded antigen tests from shelves on a voluntary basis after advice from the Health Products Regulatory Authority.
HPRA said it has received more than 550 complaints from people saying the Genrui kits have provided false positive results.
Genrui have said it is working closely with local agents and partners in Ireland, to actively investigate the product batches where it has received complaints by users.
The company, based in China, said it is also maintaining active communication with users who submit queries to Genrui to ensure the proper handling of related issues.
The Genrui brand is not is used by HSE for close contacts, the health service confirmed.
On Wednesday, HPRA said it was examining a number of reports of false positive results from the kits, which are sold in supermarkets and other outlets in Ireland.
Genrui Biotech Inc said that antigen tests have their limitations and the self-testing product cannot be used alone for the diagnosis of Covid-19.
“The test result should be combined with other diagnostic information, such as a PCR test, to determine whether the user is infected,” the company said.
Genrui said that accuracy of test results depend on a variety of factors, including standardised sampling, the time of result interpretation, ambient temperature and operating procedures.
It said that users are advised to strictly follow the instructions on use, to reduce the possibility of inaccurate results.
The company said that its self-testing kit was successfully granted the self-test permission urgently authorised by Germany, France, Portugal, the Czech Republic and Austria since 10 April last year.
Last August, it was also issued with the EU self-test CE certification.