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Thousands told to take pregnancy tests again after recall of faulty kits
Last updated at 20:22pm on 08.06.07
Home kits are not affected
Tens of thousands of women are being advised to take new pregnancy tests after it was found that some kits given out by NHS hospitals were faulty.
Fifty hospitals are trying to trace up to 80,000 women who were tested using the Clearview HCG kits in March and April.
Some of the tests have since been found out to be faulty - giving negative results even though the woman may in fact be pregnant.
So far at least one woman has proved to be pregnant after using one of the faulty batch.
The discovery has raised concerns that some women may have been putting their babies at risk of harm by continuing to drink alcohol.
Doctors are urging anyone who thinks they may have had one of these pregnancy tests to visit their GP or a hospital or buy another testing kit from a chemist.
But the U.S. manufacturer of the faulty kits is refusing to reveal publicly which hospitals are affected - for fear of breaching patient confidentiality.
This is making it harder to get the message out to the woman involved.
The firm, Inverness Medical Innovations, says there are 44 potentially erroneous test kits out of a batch of 83,000, although the Government's safety watchdog says as many as 100 may be faulty.
The problem does not affect over-the-counter kits - only those used in hospitals when, for example, a woman goes into an A&E department with abdominal pains.
But there were also indications last night that some of the kits may have been passed on to local GPs - complicating the task of locating the women affected.
Annette Briley, a midwife at baby charity Tommy's, said: "All women will worry about their baby during pregnancy and this will give them extra ammunition.
"There's very little they can do at this stage. They should get medical advice as soon as they can and move forward.
"To be falsely reassured that you are not pregnant and then you are is not good.
"But you can't turn the clock back - what's done is done. If you are one of those who finds out they are pregnant after all, I am sure the NHS will be very considerate in trying to deal with that and lessen the anxiety.
"A worried mother can adversely affect a pregnancy.
"We would always advise those who think they may be pregnant not to drink or smoke in the early weeks because that is when the baby is being built."
The problem came to light last month when a patient came forward who had received a negative result using a Clearview test from the faulty batch.
A test from a different Clearview batch returned a positive result and the pregnancy was confirmed by ultrasound.
The product was recalled, but there was a three-month gap between the delivery of the first faulty tests to the NHS and the recall on May 31.
The Patients' Association criticised the decision not to name the hospitals, saying it could leave thousands of women panicking.
A spokesman said: "This is one of the most important tests that women take and it's important that they have absolute confidence in this.
"For the company and anyone else not to be frank about the situation is not on. It's such an important test that people have to be told the truth."
The Government's safety watchdog, the Medicines and Healthcare products Regulatory Agency, said hospitals had been advised not to use kits from the faulty lot - HG0050.
The agency said the company had told it that "around 100" kits were affected.
One hospital involved is Kingston Hospital in South-West London, which is trying to contact 1,400 women tested between April 12 and June 1.
A spokesman for Unipath, a division of Inverness Medical Innovations, said an investigation had traced the fault to a strip of material that was incorporated into 44 test kits.
It said the fault was not picked up by normal checks because it was in such a small proportion of the 83,000-kit batch. The manufacturing process has now been changed.
The Royal College of Obstetricians and Gynaecologists said any woman worried about her test should contact her GP or hospital, or carry out another test at home.
