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Two batches of Genrui antigen tests were contanimated, manufactuer says

The HPRA says it has received more than 1,350 reports of false positive results from people who'd used the Genrui rapid tests.
Stephen McNeice
Stephen McNeice

16.02 18 Jan 2022


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Two batches of Genrui antigen...

Two batches of Genrui antigen tests were contanimated, manufactuer says

Stephen McNeice
Stephen McNeice

16.02 18 Jan 2022


Share this article


It has been confirmed that two batches of Genrui antigen tests were contaminated.

The HPRA says it has received more than 1,350 reports of false positive results associated with the rapid tests, which were on sale in the likes of Lidl and Dunnes.

Retailers were asked to stop selling the tests earlier this month after the issue was identified.

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The regulator now says the manufacturer has "identified an issue relating to contamination of the sample diluent for two specific batches - 20211008 and 20211125".

They'd previously asked retailers to voluntarily recall the tests, but have now issued a safety notice alerting all retailers, distributors and members of the public about the issue.

In a statement, the HPRA said: "If members of the public have not already returned these self-tests under the voluntary removal from sale, they should immediately identify any Genrui self-tests in their possession with the batch number 20211008 or 20211125.

"These self-tests should not be used and can be returned to the retailer where they were purchased."

Genrui has temporarily suspended the sale of the tests to Ireland while the recall is ongoing.

The HPRA says other EU member states have not seen the same high number of false reports, but Spanish authorities have temporarily suspended the sale of the tests as a precaution.

The Irish regulator adds that it has not received a high number of false negative or positive results from other antigen test kits.

Genrui tests are manufactured by Genrui Biotech in China, and have been approved for use in the EU.


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