News Category: Regulatory news
Update 18 January 2022
The HPRA has today issued a safety notice to raise awareness of a product recall of two batches of the Genrui SARS-CoV-2 Rapid Antigen Self-Test. This recall action follows on from the voluntary suspension from sale of the Genrui self-test by retailers in Ireland on 5 January, after the HPRA received in excess of 1,350 reports from consumers of false positive results associated with its use.
The manufacturer has identified an issue relating to contamination of the sample diluent for two specific batches; 20211008 and 20211125. These batches are being recalled from affected retailers and members of the public. Any distributor or retailer supplying this antigen self-test should read the safety notice and follow the actions outlined. Retailers in Ireland are advised to continue the voluntary suspension from sale of the Genrui self-test while the recall is ongoing.
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.
The HPRA is continuing to liaise with the manufacturer and our assessment of the issue remains ongoing. The safety notice will be updated should further information become available. The manufacturer has temporarily suspended the sale of Genrui self-tests to Ireland on a voluntary basis while the recall is ongoing.
Feedback from other European Competent Authorities indicates that other member states are not experiencing the same high number of reports of false positive results with this particular test. The Genrui self-test has been temporarily suspended from sale on the Spanish market as a precautionary measure.
The HPRA has not received a high number of reports of false negative or false positive results for other rapid antigen self-tests.
Due to high volumes of reports, individuals who report to the HPRA may not receive a response directly and relevant updates will be published on our website. Individuals/users can report incidents with antigen tests or any other medical devices via the HPRA online reporting form.
If you experience a positive result following the use any rapid antigen self-test, including this test, you should follow the current public health advice on the HSE website.
Update 5 January 2022: HPRA advises precautionary removal from sale of Genrui SARS-COV-2 Rapid Antigen Self-Test
The Health Products Regulatory Authority (HPRA) today states that based on its advice, retailers are removing the Genrui SARS-CoV-2 Rapid Antigen Self-Test from sale on a voluntary basis pending further investigation. This follows receipt by the HPRA of over 550 reports in recent days from Irish consumers of false positive results associated with the use of this particular antigen self-test.
Rapid antigen tests, like all diagnostic tests, have the potential to provide false negative or false positive results. However, 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. The HPRA also advises against the online purchase of Genrui self-tests at this time while the matter remains under investigation.
Individuals who have received a positive result following use of any rapid antigen self-test, including this test, should follow the current public health advice on the HSE website.
The HPRA will continue to liaise with the manufacturer to investigate the matter further, and is also in contact with other European Competent Authorities in relation to this issue.
Individuals who have experienced a false positive or false negative result can report the occurrence via the HPRA's reporting form.
The HPRA wishes to acknowledge the cooperation and swift response of retailers in relation to this matter. Any retailers supplying this product who have not yet received communication in respect of this issue should contact email@example.com.
Káno Communications Tel: (01) 679 8600
Siobhán Molloy / Kathryn Moley (086) 817 5066 / (086) 733 4438
The Health Products Regulatory Authority (HPRA) is the competent authority in Ireland for the purposes of In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD), which has been transposed into Irish law by the European Communities (In vitro Diagnostic Medical Devices) Regulations 2001 SI 304/2001 as amended.
Rapid antigen tests used to detect Covid-19 are in vitro diagnostics (IVD) and form part of the public health response to Covid-19 in Ireland. Within the European medical devices legislative framework, the HPRA does not approve or certify rapid antigen tests for sale in Ireland or any other country.
Rapid antigen tests placed on the Irish or European market must conform to the requirements of the relevant European legislation and tests that are appropriately CE marked may be freely placed on the European market. Rapid antigen tests that are intended by the manufacturer to be used as self-tests in a home environment require an additional assessment by a notified body on the suitability of the device design and the information included on the label and the instructions. Self-tests should bear the CE mark and a four-digit identification number of the notified body. For further information, please see the HPRA website page for IVDs for SARS-CoV-2.