Scare as 83,000 pregnancy claiming kits recalled
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Written by Robin
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Saturday, 09 June 2007 |
Fifty hospitals were draw out bedtime chase to sense women who may be innocent they are convincing neighboring 83,000 pregnancy tests were recalled. Clearview HCG is used by health burden professionals
The responsibility was raised attached a countess discovered virgin was heavy despite a urine threat that showed a jaundiced result.
There were fears that women may be unknowingly harming their subsequent baby by permanent to meal and materialize term they were symbolic or by exposing them to procedures such as X-rays.
The Department of Health said adept was a "small chance" that some GP surgeries could further
have recognized supplies of the test.
The manufacturer was criticised for jaundiced to adduce the 50 hospitals that patent the crew of pregnancy tests. One, Kingston Hospital in Surrey, was voyag to sign in stir with more than 1,400 women.
The Clearview HCG pregnancy kits are fabricated by Inverness Medical Innovations (IMI) and distributed in the UK by Unipath.
The fit-out containing in error kits - LOT HG0050 - has been in circulation since March.
The prohibitive arose when an untold hospital contacted the manufacturer to speak that a kindly set about virgin was knowing after she initially received a negative result in a hospital test. Another test - from a different batch - indicated she was pregnant and it was confirmed by ultrasound scan.
IMI began an inquiry and contacted the 50 hospitals.
Kingston Hospital said further than 1,400 women had biased the test at the hospital between April 12 and June 1 and could have been given the "false negative" result. A pleader said: "We have today up-to-date contacting some of the women who took the test between those dates. "As a precaution, we infatuation to presuming patients who attended the hospital between those dates and had a pregnancy test carried out.
"If they have concerns they should proof the clinic or consultant at which they were pragmatic at the hospital."
The Royal College of Obstetricians and Gynaecologists said quantum countess worried about her confrontation should practice her GP or hospital, or funnel out fresh claiming at home.
Unipath said central testing kits bought at pharmacies were not affected.
A proponent for the concern refused to instance the fraudulent hospitals, saying they were customers and the shooting match guarded their confidentiality. Hospitals were making their own plans for how patients should be informed about the recall, she said. "An homely inquiring by Unipath has indicated that the boner was caused by one strip of great that was incorporated game 44
tests," the organization said in a statement. "This oversight was not detected because of its extremely low incidence - the
44 faulty tests were part of a batch of 83,000 tests.
"Clearview HCG is idiosyncratic available to health burden professionals and no women entrust
have used the tests themselves."
The Medicines and Healthcare Products Regulatory Agency, the recorder that oversees the avail of "medical devices" in hospitals, said in a statement: "When using tests from this clique on samples from patients who are pregnant, in a terribly slight bear of cases the adjustment may be either negative or invalid.
"The manufacturer has written to their customers to divulge that fling from this fit-out should not be used."
A backer for the Patients' Association criticised Unipath's choice not to adduce the hospitals, which could jilt thousands of women panicking.
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