Falsified Medical Product Alert N°2/2020
Uni-Gold HIV rapid diagnostic test (product code 1206502): falsified product alert
WHO issued this alert after its Global Surveillance and Monitoring System was informed that at least 8,240 falsified Uni-Gold HIV tests had been distributed to end users in Guyana. Later reports showed the same falsified product circulating in Kenya. The page was updated on 1 April 2020.1
Health risk as statedWHO said use of the falsified test is likely to lead to delayed diagnosis of HIV status.
- Issued
- 27 March 2020
- Issued by
- World Health Organization
- Name stated on packaging
- Trinity Biotech, stated on the packaging
- Genuine manufacturer's statement
- WHO said Trinity Biotech plc stated it did not manufacture the falsified product. Genuine lots HIV7120026 and HIV6120030 expired in 2019 and the stated expiry dates do not match its records.
- Countries where detected
- Guyana, Kenya
Batches named in the alert
HIV7120026 (stated expiry 5 DEC 2020), HIV6120030 (stated expiry 29 JUL 20)
Advice as stated
Do not use the affected kits. Notify the supplier and national health authorities. Obtain medical products only from reliable sources.
Names printed on falsified products are not evidence that the named company made them. Where WHO or a regulator reports the genuine manufacturer's statement, it is shown.
Sources
- World Health Organization, Medical Product Alert N°2/2020: Falsified HIV rapid diagnostic tests (27 March 2020)