Press release: Men urged to seek advice due to faulty prostate cancer home test kits

Press release

Date:	4 November 2009
Time:	10:00
Contact:	Press Office 020 7084 3651/ 2657 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

Men who have used ‘Simplicity Health’ or ‘Fortel’ home testing kits for prostate cancer screening during the past 12 months are being urged to contact their GP for advice.

This follows recent notification to the Medicines and Healthcare products Regulatory Agency (MHRA) that the two kits from batch number 1012 are faulty and could give a false negative result.

The 1000 defective devices shipped to the UK were sold through pharmacies and via the internet. Men who have used these kits and have since discarded the packaging may not be able to identify if theirs was faulty.

MHRA Director of Device Technology and Safety, Clive Bray, said the Agency was not aware of any adverse incidents relating to this device.

“However, we are strongly recommending that men who may have purchased and used one of these kits contact their GP for advice.

“The risk of obtaining a false negative result due to a faulty kit is low, but could lead to a missed diagnosis.”

The kits were manufactured by Biomerica Inc USA and distributed in the UK by BHR Pharmaceuticals Ltd and Simplicity Health Ltd.

Pharmacists have been notified to cease sale of this stock, discard it, and contact their supplier for replacement products.

Notes to Editor

1. Following an in-house study, Biomerica Inc sent a Field Safety Notice to the supplier in August 2009 and the MHRA was notified of this, which suggested reduced product stability in the device. Reduced stability in this device may lead to a false negative result if patient samples are at, or near, the detection level of 4ng/ml for the rapid test device.

2. Simplicity Health Ltd distributed the kits in the UK along with business partners:

• Simplicity Health
• Worldwide Shopping Mall
• Self Diagnosis.

3. Pharmacists are urged to advise patients who may have used this stock with this lot number to contact their GP for advice.

4. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.