Pregnancy test kits recalled after fault concerns

Doctors and health workers in England were today warned not to use a pregnancy testing kit on patients after concerns emerged that some women could have been given incorrect results.

The Medicines and Healthcare Products Regulatory Agency (MHRA) said it had identified a problem with the SAS 1 Step testing kit, which is used by GPs, clinics and hospitals.

The fault meant that women could have been told they were not pregnant when they actually were - known as a "false negative" result.

The MHRA said it would be issuing "urgent advice" on Thursday about the recall of the kits which have not yet been used.

The Department of Health said they did not know exactly how many kits had been distributed across the UK, but the figure is likely to run into tens of thousands.

The testing kits were made by US firm SA Scientific.

One of the areas affected - County Durham and Darlington Acute Hospitals NHS Trust - earlier said they had contacted 560 women who had been given the test.

The kits are not available over the counter and women who bought tests to use at home are not affected.

Dr Sue Ludgate, medical director at the MHRA, said the kit had been submitted for independent testing and they would issue full advice on Thursday.

"In the meantime, clinicians and health professionals should not use this pregnancy kit, and should retest those patients who may be adversely affected by a falsely negative result," she said.

"I appreciate that some women will be understandably concerned at this news.

"Women who have had a pregnancy test in a GP surgery, health clinic or in a hospital over the previous twelve weeks, which proved negative, and are concerned that they may still be pregnant, should contact their GPs or hospital consultants for a new appointment, or ring NHS Direct for further advice."

The DoH said only a small number of women would probably have been affected by a false negative result.

In a statement the County Durham trust said they had identified a "possible problem" with a batch of around 3,000 kits issued to clinics, GP practices and hospitals in the area.

The checks found an "unexpectedly high rate of false negatives".

Bob Aitken, medical director of the trust, said: "Routine quality control checks were carried out on a batch of pregnancy testing kits used in general practice, family planning clinics, young persons clinics and some pharmacies in Durham and Chester-le-Street and Derwentside, and used in University Hospital of North Durham.

"No tests are 100% accurate, however these quality checks resulted in an unexpectedly high rate of false negatives.

"This means that the test may have given a negative result even though the woman was pregnant.

"When we became aware of the possible problem, this batch, which was in use between October 1, 2003, and January 29, 2004, was withdrawn.

"Since January 29, an alternative batch has been in use."

Mr Aitken, a consultant in obstetrics and gynaecology, said they had reported their concerns to the supplier of the kits and the MHRA.

The trust has contacted around 300 women who had a negative test result when the kit was used in general practices, clinics and pharmacies in Durham and Chester-le-Street and Derwentshire.

The trust has also contacted 260 women who tested negative during routine procedures before having treatment at University Hospital of North Durham.

A spokesman for SA Scientific in San Antonio, Texas, said: "We have asked for a sample of the kits to be sent back to us so we can do some testing here.

"All our products are fully tested before they are shipped out.

"These kits are widely used in the US and we have not had any reports of problems here."