The recall affects Lot 2003014, Model numbers SA8091 or SA8091R of the product.
The fault causes the thermometer to read two degrees Celsius higher than it should, which is a safety concern for patients who are monitoring their temperature, particularly in view of the pandemic. Most of the affected thermometers have been successfully recalled but there are an estimated 1,000 in circulation. The MHRA has also been working with the company to ensure that no further thermometers with this fault are sold to the public.
If patients think they may have bought one of these thermometers, they should check the model numbers and lot numbers, which are listed on the box and on the thermometer. They should return them to the shop where purchased, or contact the manufacturer, who will send them a prepaid envelope for the return. Once returned, the manufacturer will send a replacement.
Customers can check if their products are affected by checking the lot number on the box of their thermometer (or on their thermometer) against the list published by Murray Health in the company’s field safety notice. Pictures of where to find the lot number are in the field safety notice.
Dr Janine Jolly, MHRA Group Manager, Device Safety and Surveillance, comments:
“While the risk is low, the MHRA takes the safety of the medicines and devices we regulate very seriously.
“It is therefore important that as many customers as possible check their thermometer for these lot and model numbers.
“Users with concerns should talk to their GP or healthcare professional. They can also report any adverse effects to the MHRA’s Yellow Card scheme. This helps make medical devices safer for everyone.”
Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.