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Genrui antigen tests
# false positives
Some Genrui antigen tests recalled from shelves over false positives
Genrui Biotech Inc, who manufacture the tests, have issued a product recall for the impacted batches.
A NUMBER OF Genrui antigen tests have been recalled from Irish shelves after the manufacturer confirmed a contamination issue was causing false positives.
In a safety notice issued by the Health Products Regulatory Authority (HPRA), Genrui Biotech Inc confirmed that there was a contamination issue with two specific batches of the antigen tests.
An investigation was carried out by the company and the contaminated batches were determined as 20211008 and 20211125.
The faulty batches stem from a contamination issue with the sample diluent, say Genrui.
“It has advised that no other batches are impacted by this issue and that the reliability of negative results is not affected by this issue,” said the HPRA in a statement.
It has not been confirmed how many tests this has impacted
There were over 500 reports of false positives being reported by Irish consumers who used the Genrui antigen tests, with the HPRA advising retailers to remove the antigen test brand from sale until further notice.
According to the HPRA, the manufacturer is now recalling these specific batches from retailers and members of the public.
“The manufacturer is now recalling these batches from affected retailers and members of the public. Retailers in Ireland are advised to continue the voluntary suspension from sale of the Genrui self-test while the recall is ongoing,” said the HPRA.
The sale of Genrui antigen tests will also continue to be suspended while the recall is ongoing.
HPRA advice
Current advice from the HPRA for people who are in possession of Genrui antigen tests is to identify the batch number, and if they fall into a contaminated batch they should not be used.
People should then return the antigen tests to the retailer they were bought at.
However, people who received a positive result from the antigen tests, they should continue to follow public health advice which is available on the HSE website.
The HPRA is also advising anyone who received a false positive to report it to them through their reporting form.
Retailers have been advised to immediately “identify and quarantine” stock with the contaminated batch number.
They are also being advised to send a copy of the HPRA safety notice to members of staff who need to be aware of the issue, and to customers who may have bought the impacted tests.
Last week, EU experts discussed the reports of false positives arising from the antigen tests.
The tests were discussed by the European Commission’s Technical working group on Covid-19 diagnostic tests, which comes under the remit of the Health Security Committee.
Following the meeting, a commission official told The Journal that while the committee does not review antigen tests for self-testing, it would be closely monitoring the situation.
“This rapid antigen test is widely used in several EU Member States for professional use and countries are closely monitoring the situation,” said the commission official.
“The technical working group (TWG) agreed that it is the role of the national competent authorities to carry out the necessary investigations (which are indeed ongoing) and that the TWG should wait for these results to become available before taking action, if required.”
