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Genrui SARS-CoV-2 Antigen Test Kit Recall Overview:
- Who: The Irish Health Products Regulatory has issued an urgent safety notice over defective COVID-19 tests.
- Why: Two batches of the Genrui rapid result tests have been recalled due to contaminated testing fluid.\
- Where: The recall is effective in Ireland.
Ireland’s The Health Products Regulatory Authority (HPRA) has issued an urgent safety notice to raise awareness of a recall of two batches of the Genrui SARS-CoV-2 Antigen Self-Test Kit (Colloidal Gold).
The HPRA received a high number of reports from Irish consumers that the tests were giving false positive results, the notice says. Because of that, HPRA urged retailers in Ireland on Jan. 5 to remove the Genrui tests from sale on a voluntary basis while the manufacturer investigated.
Contaminated Sample Fluid Causing False Positives
Genrui Biotech did investigate the high number of reports of false positives and found there was contamination of the sample diluent in two specific batches: 20211008 and 20211125.
The manufacturer is now recalling these batches from affected retailers and members of the public, the notice explains.
HPRA is urging retailers in Ireland to not to sell the Genrui self-tests while the recall is ongoing, saying “these self-tests should not be used.”
It is also urging consumers to return any of the tests they may have to the store of purchase.
“If you received a positive result following the use of any rapid antigen self-test, including this test, you should follow the current public health advice on the HSE website,” the notice says.
HPRA added that if consumers experience a false positive or negative result from the self-test, or any other rapid antigen test, it can be reported via the HPRA’s reporting form. The agency says it is continuing to liaise with the manufacturer, which has stopped sale of the tests to Ireland during the recall.
In the U.S., approximately 200,100 Flowflex SARS-COV-2 Antigen Rapid Tests (Self-Testing) were recalled by the Food and Drug Administration (FDA) this week, as the tests were never granted approval by the agency. In a recall notice, the FDA says the tests have not been authorized for emergency use to test for COVID-19 and “cannot be determined to be adequately validated for the stated intended use.”
Have you used a Genrui test before? Let us know how it worked for you in the comments section below!
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