Number of false positives leads to warnings on pregnancy testing kit in Ireland
A warning has been issued about the effectiveness of a pregnancy health kit on the Irish market.
The warning, issued by the Health Products Regulatory Authority formerly the Irish Medicines Board, was made after a number of ‘false positives’ were reported.
The authority is asking women who use the Clungene Pregnancy to report any concerns they have about the product.
The pregnancy testing kit is manufactured in China and is distributed in Ireland by Kora Healthcare.
“The HPRA has been notified of the occurrence of false positive results with Clungene Pregnancy tests lot numbers 13122001 and 14060301. The Irish distributor Kora Healthcare has confirmed that these devices are on the Irish market,” the authority said on their website.
“The manufacturer is currently investigating this issue. Users are advised to exercise vigilance using this product pending completion of the manufacturer’s investigation.”