IRELAND is not affected by a major pregnancy test recall – as women in the UK are being urged to double check the results of at-home pregnancy tests over fears they gave the wrong results, experts said today.
Some 58,000 faulty Clear and Simple digital pregnancy tests are being recalled in the UK after a number of the at-home testing kits provided false positive results.
Ireland is not affected by this recall, according to the manufacturer, but it is warned that users may have purchased the products online.
The Health Products Regulatory Authority of Ireland advised: “HPRA has been advised by the manufacturer of this device that Ireland is not affected by this recall.
“As with any medical device, it is possible that users may purchase this device online.”
However there are fears that customers in Northern Ireland may be supplied with the faulty batch.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall of the affected batches, including supplying stores in Northern Ireland.
Dr Duncan McPherson, clinical director of medical devices at the MHRA, said: “It is important people check the lot number of any Clear & Simple Digital Pregnancy Tests they have purchased to see if they have a product from an affected lot.
“If you have any questions about using digital pregnancy tests, please speak to your healthcare professional.
“Patient safety is our highest priority. We strongly encourage anyone to report any issues with this product, or more generally with any medical device, to our yellow card scheme.”
IS YOUR PREGNANCY TEST AFFECTED?
If you have recently used, or are planning to use, Clear and Simple digital pregnancy tests then you need to check the batch number before you do.
Lot number: DM10220170710E
Expiration date: Jan 2020
If you pregnancy test is from this batch you should return it to your pharmacy.
Tests on a number of kits from this batch have produced false positive results.
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A false positive pregnancy test result means you’re not pregnant but the test says you are, which may be a heartbreaking scenario for many women.
Home tests work by detecting levels of the pregnancy hormone human chorionic gonadotropin (HCG) in urine samples.
Most tests are about 99 per cent accurate when used correctly, but they are not fail-proof.
By Fionnuala Walsh and Andrea Downey
This content was originally published here.