Dáil Éireann Debate, Wednesday - 19 January 2022
1661. Deputy Colm Burke asked the Minister for Health the action that will be taken against companies which sold antigen tests in cases in which the product was subsequently recalled and proven to be defective; the measures of recourse the purchasers of the tests prior to their recall will have against the company; and if he will make a statement on the matter. [1255/22]
View answerThe Health Products Regulatory Authority (HPRA), as the competent authority for medical devices in Ireland, is currently investigating a number of reports of false positive results associated with use of the Genrui SARS-COV-2 Rapid Antigen Self-Test.
The manufacturer of this device, Genrui Biotech, has now investigated the high number of reports of false positive results and has advised that an issue relating to contamination of the sample diluent has been identified with two specific batches.
The manufacturer is now recalling these batches from affected retailers and members of the public. The Field Safety Notice (FSN) has now been agreed and published and outlines a product recall for the two batches of the Genrui SARS-CoV-2 Rapid Antigen Self-Test. The FSN has been published , yesterday January 18 2022 and the HPRA has also published a safety notice (a HPRA notice) to raise awareness of this product recall. A statement was also published on HPRA website to highlight the update on this issue.
The HPRA has advised affected retailers to continue the voluntary suspension from sale of all of the Genrui self-test while the recall is ongoing (i.e. not just affected batches being recalled via this FSN.) The manufacturer has also agreed to continue to temporarily suspend the sale of the Genrui self-test to Ireland while the recall is ongoing.
HPRA will be continuing to investigate the root cause to identify whether other batches are impacted and to ensure that a comprehensive investigation is completed and will keep DOH informed of any developments in this regard.
By way of information, all rapid antigen self-tests are regulated under EU Directive 98/79/EC on in vitro diagnostic medical devices. As per the requirements of this Directive, manufacturers are required to evaluate the performance parameters of their devices prior to placing them on the market, including the diagnostic sensitivity and specificity. Rapid antigen tests, like all diagnostic tests, have the potential to provide false negative or false positive results. However, due to the rapid rise in the number of reports of false positive results relating to this specific device, the HPRA is actively following up with the manufacturer to further investigate this issue. The outcome of this investigation will help inform if further action is required. In the interim, retailers are advised, as a precautionary measure, to remove these devices from sale and consumers are advised to avoid purchasing them online while this issue is under investigation.
