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 Uni Gold HIV is a single use rapid diagnostic test an immunoassay for the qualitative detection of antibodies to HIV 1 and HIV 2 in serum plasma and whole blood Uni Gold HIV is intended for use in point of care settings as an aid in diagnosis of HIV 1 and HIV 2 infection The WHO testing strategy recommends three HIV reactive test results to confirm an HIV positive status in a patient The use of this falsified Uni Gold HIV subject of WHO medical product alert n 2 of 2020 is likely to lead to delayed diagnosis of HIV status Table 1 Specific details of the falsified product Uni Gold HIV subject of WHO Medical Product Alert n 2 of 2020 Product Name Uni Gold HIV Lot Number HIV7120026 Expiry Date 5 DEC 2020 Stated manufacturer Trinity Biotech The packaging of this falsified HIV test kit is in English The genuine manufacturer Trinity Biotech plc has confirmed that They did not manufacture the falsified product in Table 1 Genuine lot HIV7120026 was made by Trinity Biotech plc and expired in 2019 The expiry date is incorrect and does not correspond with their batch manufacturing records Photographs and advice to the public are available below Figure 1 Falsified Uni Gold HIV lot number HIV7120026 displaying falsified expiry date Figure 2 Falsified Uni Gold HIV displaying labelling inconsistencies Advice on action to be taken by end users Please check to see if any Uni Gold HIV test kits in your facility have lot number HIV7120026 If you are in possession of these falsified test kits with lot number HIV7120026 Please do not use Please immediately contact the organization that supplied you with the product either your HIV testing programme nongovernmental organization or local distributor Please contact Trinity Biotech plc Phone 353 1 276 9800 E mail hiv trinitybiotech com Please contact your national health authorities All medical products must be obtained from authentic and reliable sources Their authenticity and condition should be carefully checked Advice on action to be taken by national health authorities WHO requests increased scrutiny within the supply chains of all countries particularly at testing sites health facilities community based clinical laboratories medical stores warehouses and at the facilities of relevant economic operators agents authorized representatives distributors wholesalers etc If these falsified test kits with lot number HIV7120026 are discovered please do not use National health authorities are asked to immediately inform WHO if these falsified products are discovered in their country using the WHO IVD complaint form If you have any information concerning the manufacture distribution or supply of this product please contact rapidalert who int WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products For further information please visit our website https www who int medicines regulation ssffc en