UK acts on faulty prostate cancer home-testing kits
This article was originally published in Clinica
Executive Summary
The UK's Medicines and Healthcare products Regulatory Agency today issued an alert urging all users of prostate cancer home-test screening kits manufactured by Biomerica in the last 12 months to seek medical advice. A single batch of 1,000 kits branded "Simplicity Health" or "Fortel" were the subject of a field safety notice issued by the Newport Beach, California firm to its distributors in August 2009, related to a "reduced stability" fault that posed a risk of a false negative. After recalling the faulty batch, the MHRA is now acting on concerns that users of kits may not be aware of the situation, or not able to trace the batch number.
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