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Thousands of women in Britain may have been given faulty pregnancy tests that wrongly indicate they are not having a baby, the Independent has learned.
Up to 50 hospitals across the country are seeking to trace women who may be unaware they are pregnant because of a faulty
batch of Clearview HGC.
There are believed to be 44 potentially erroneous tests but tens of thousands of women may have been given the product in the past three months before the problem was spotted.
The NHS is unsure which women received the faulty tests and one general hospital is seeking to alert 1,400 women.
Tracing the women is important in case they endanger their baby by drinking heavily or by engaging in other activity unsuitable behaviour.
Clearview HGC tests, made by the US-based Inverness Medical Innovations, are also designed to detect ectopic pregnancies.
The abnormality, where the baby grows outside of the womb, can cause severe internal bleeding.
The tests are also often used in accident and emergency departments.
Last night Inverness Medical Innovations said it was confident that it had rectified the problem, which occurred when an extra strip was added to the tests during production.
It said: "We would like to apologise for any inconvenience this recall may have caused to our customers or their patients." Doctors are urging anyone who may have received the tests to visit their GP, local hospital or to buy a pregnancy testing kit from a chemist.
At least three months elapsed between the delivery of the first faulty products to the NHS and a product recall begun last week.
The fault was spotted by one unnamed hospital, which contacted Inverness Medical Innovations.
The US global health care group then began an investigation that culminated in a product recall on May 31, when it wrote to up to 50 hospitals.
It said in a statement: "Our investigation indicated that the fault was caused by one strip of material that was incorporated into 44 tests, so, our investigation indicated the problem was limited to 44 tests.
"We determined that these 44 tests could be in up to 50 specific hospitals and we immediately alerted the hospitals concerned.
"We are confident that the problem has been correctly diagnosed and is being rectified by changes to our manufacturing process." However it refused to say which hospitals were affected, citing customer "confidentiality." Kingston Hospital in south-west London disclosed that 1,400 women were tested with Clearview HGC between April 12 and June 1.
It said in a statement: "We have been made aware by a supplier that a small number of pregnancy test kits that may have been used at the hospital could be faulty.
"The kit could give a false negative test result.
"These test kits are used quite widely across the hospital, but in the main are used in accident and emergency." Kingston added: "As a precaution, the hospital wishes to alert patients who attended the hospital between April 12 and June 1 2007 and had a pregnancy test carried out, and that if they have concerns to contact the clinic or consultant where they were seen at the hospital." The Government watchdog, the Medicines and Healthcare Products Regulatory Agency, said hospitals had been advised not to use the product from the faulty lot - HG0050.
An MHRA spokeswoman said: "The affected lot was distributed to UK hospitals between March and April this year.
"When using tests from this batch of product on samples from patients who are pregnant, in a very small number of cases the result may be either negative or invalid." The MHRA said it intended to publish the manufacturer's recall letters and to issue further advice to the health service.
- INDEPENDENT
