Accra, April 15, GNA – The Food and Drugs Authority (FDA) has received a notification through the World Health Organisation Global Surveillance and Monitoring System for substandard and falsified medical products.
A statement issued in Accra by Mrs Delese A. Darko, the Chief Executive Officer, FDA said these substandard and falsified medical products falsified rapid diagnostic tests to detect HIV-1/2 have been distributed in Guyana at the end-user level.
It said the product was Uni-Gold HIV and claimed to be manufactured by Trinity Biotech Plc with subsequent reports revealing that the same falsified products were also been circulated in Kenya.
Uni-Gold HIV is a single-use rapid diagnostic test, which was an immunoassay for the qualitative detection of antibodies to HIV-2 in Serum, plasma and whole blood.
Uni-Gold HIV is intended for use in point of care as an aid in the diagnostic of HIV-1 and HIV-2 infection.
It called on the public to report or seek clarification on any suspicious product intended for diagnosis of HIV-1/2 that they have encountered with the FDA.
The statement assured the public of the readiness of FDA officers in the regions to ensure that these products do not enter the supply chain.
GNA