Medical Product Alert N°2/2020 Falsified HIV rapid diagnostic test circulating in the WHO regions of the Americas and Africa

This Medical Product Alert relates to a confirmed falsified human immunodeficiency virus (HIV) in vitro diagnostic medical device (IVD) that has been identified circulating in Guyana and Kenya.

Through its Global Surveillance and Monitoring System (GSMS) for substandard/falsified medical products, WHO was informed that at least 8,240 falsified rapid diagnostic tests to detect HIV-1/2 have been distributed in Guyana at end-user level. The product is Uni-Gold™ HIV and claims to be manufactured by Trinity Biotech plc. Subsequent reports revealed that the same falsified product is also circulating in Kenya.