Number of false positives leads to warning on pregnancy test

A warning has been issued about the effectiveness of a pregnancy test kit after healthcare professionals reported a number of false positives.

The Health Products Regulatory Authority, formerly the Irish Medicines Board, has advised users of the Clungene Pregnancy Test to report any concerns about the product to the authority.

A spokeswoman for the authority said about 1,100 test kits, each containing 20 sticks, were supplied to the Irish market. The lots affected are Lot 13122001 (973 boxes) and Lot 14060301 (201 boxes).

The spokeswoman said while they had received “a small number of reports from health professionals in Ireland relating to false positive results”, “no adverse health consequences have been reported for any of the patients involved”.

The spokeswoman said she understood it was very much an “Ireland specific” problem at this time, although the product is potentially available in all European countries. She said the authority does not have any information on the usage of the product in other countries.

The spokeswoman confirmed an investigation into the issue is ongoing.

The authority has issued a safety notice to advise users to be vigilant using the device. It will issue additional advice “in due course when the manufacturer’s investigation into this issue is complete”, the spokeswoman said.

If the outcome of the manufacturer’s investigation indicates that market action is required, all other potentially affected countries will be notified, she added.

The safety notice was issued on Tuesday. The manufacturer of the product is Hangzhou Clongene Biotech Ltd, which has headquarters in China. The distributor is Kora Healthcare, based in Swords, Dublin.