The Medicines and Healthcare Products Regulatory Agency is investigating false negative results in one lot of Clearview HCG pregnancy test kits (lot HG0050). The affected lot was distributed to UK hospitals between March and April this year.
The manufacturer (Unipath) has written to their customers to inform them of the problem and advised that the product from this lot should not be used (see download document below). The MHRA plans to issue further advice to the health service.
Women who have had a negative pregnancy test and who are concerned that they may be pregnant should make an appointment to discuss these matters with a doctor or seek advice from a walk-in centre, family planning clinic, sexual health clinic or pharmacist.
MHRA has been informed of a patient who received negative test results when tested with lot HG0050 of this kit. A test with another lot of the same product gave a positive result. The pregnancy was confirmed by ultrasound.
The manufacturer has recalled this batch of product. The manufacturer has determined that this problem was caused by a single manufacturing fault that was not detected by routine quality control checks.
The Medicines and Healthcare products Regulatory Agency has published the manufacturer?s recall letters on its website and is planning to publish a Medical Device Alert to the health service advising users to stop using this kit and to develop a policy to review high risk patients.
The UK manufacturer informed MHRA that around 80,000 test kits from lot HG0050 were distributed in Europe in March and April 2007, and the manufacturer has estimated that around 100 test kits were affected by the manufacturing fault.
Clearview pregnancy test kit is intended for use in hospitals and not sold over the counter for home use. MHRA is not aware of problems with any other pregnancy test kits (Unipath?s Clearblue pregnancy test kit which is intended for use at home is not affected by this recall).