Pregnancy test kits delivered to 22 public and private hospitals across the State were recalled by their manufacturer yesterday after it emerged some kits in the batch they came from were faulty.
The kits, manufactured in the UK, were delivered since the end of March.
There were 83,000 pregnancy test kits in the faulty batch and about 10,500 of them are understood to have been sent to the Irish hospitals.
Up to 50 hospitals in the UK are also affected and at least one woman there who was misled into thinking she was not pregnant after she was given the test has come forward.
Irish women who were given the tests are due to be contacted directly by their hospitals. These women may have to retake a pregnancy test.
Unipath, the manufacturer of the Clearview HCG pregnancy test kit, said it was up to the hospitals themselves how they communicated with or traced the patients who were given the tests.
The particular pregnancy test kit involved in the recall is only available in hospitals and clinics for use by professional staff. It is not on sale for home use.
The Irish Medicines Board (IMB), which is overseeing the recall, said the manufacturer had indicated to it that a maximum of 44 kits from the batch of 83,000 may be affected or faulty.
A spokeswoman said: "The IMB understands that affected batches have been distributed to 22 public and private hospitals across Ireland. The IMB understands that each affected hospital has been informed of the recall by the manufacturer/device distributor.
"The IMB understands that these devices were supplied to Irish distributors at the end of March 2007. Indications from the distributors suggest that not all the product has been used by the hospital/clinic sites. The IMB will continue in communication with the manufacturer to ensure completion of this recall action."
Unipath would not name the hospitals involved in the recall.
Pregnancy tests are carried out in hospitals to detect pregnancy as part of the investigation of certain patient symptoms or illnesses as well as to ensure a patient is not pregnant before given any treatment that is contraindicated for pregnant women.
The Health Service Executive has been contacted about the recall by the manufacturer.
Unipath, in a statement, said an internal investigation has indicated that the fault was caused by one strip of material that was incorporated into 44 tests. As a result, they give false negative results. "Unipath is confident that the problem has been correctly diagnosed and is now being rectified by changes to the manufacturing process," it said.