HIV Medical Devices May Give Incorrect Results

Government Sends Alert Over HIV Tests Calling For A Recall And Retest For Patients


Saffron Otter, Press Officer | 0114 276 4666

Product liability experts at national law firm Irwin Mitchell call for a thorough investigation to identify patients who have received an inaccurate result after the Government Medical Device Regulator (MHRA) urges a recall on medical devices used to test for HIV.

A medical safety alert has been issued by the MHRA concerning devices that may give an incorrect false negative or false positive result when testing for HIV, HCV, and HBV, which are used at medical clinics. 

Certain devices manufactured by Hangzhou Biotest Biotech Co Ltd are subject to the recall. These include the RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapid Test Cassette & HBsAg Rapid Test Cassette.

The government alert warns: not to use the devices; to identify and dispose of the devices affected by this action; where they have been used to retest all patients; and ensure that all relevant staff members understand the problem and the actions to be taken. 

The tests are distributed across the UK from NHS walk-in centres, A&E departments, to GP practitioners. 

The recall comes amid Prince Harry’s live HIV testing which encouraged people to get tested. This inspired a 500% increase in people checking their status, according to The Terrace Higgins Trust.

Kevin Timms, product liability expert at Irwin Mitchell, said: 

Expert Opinion
“HIV tests are so crucial to NHS healthcare with thousands of patients taking these tests and a quick turnaround of results. A thorough investigation needs to be carried out to identify which patients have been tested under this product, and for them to be contracted and re-tested to make sure they receive an accurate result.

“Clearly this will result in a substantial exercise for the NHS at considerable cost. Although the cost of the test is inexpensive with test kits provided free of charge, the cost to the NHS will be huge – making an impact on resources and other patient care.

“As with any medical analysis, being told you have HIV when you don’t, and vice versa, can have a profound psychological impact on a patient. The NHS must ensure that these patients are at the centre of care, receive accurate medical advice and guidance needed after diagnosis.”
Kevin Timms, Solicitor

Our specialist medical negligence solicitors will provide you with free initial advice on your compensation claim if you have suffered as the result of a defective or faulty medical products or medicines. View our Defective Medical Products Drugs Or Medicines Claims page for more information.