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Medical Product Warning no. 2/2020
This medical product alert is for a verified fake human immunodeficiency virus in vitro diagnostic medical device (IVD) that has been identified to be circulating in Guyana and Kenya.
Through your own Global Monitoring and Control System (GSMS) for substandard / counterfeit medical devices,
The WHO has been informed that at least 8,240 counterfeit rapid diagnostic tests for the detection of HIV-1/2 have been distributed in Guyana at the end-user level. The product is Uni-Gold ™ HIV and claims to be manufactured by the company
Trinity Biotech plc. Subsequent reports
found that the same counterfeit product was also circulating in Kenya.
Uni-Gold ™ HIV is a rapid, single-use 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 at the point of care as an adjunct
in the diagnosis of HIV-1 and HIV-2 infection.
WHO testing strategy recommends three HIV reactive test results to confirm HIV positive status in a
patient. Use of this counterfeit Uni-Gold ™ HIV, with WHO medical device alert no. 2 of 2020 is likely to lead to a delayed diagnosis of HIV status.
Table 1: Specific details of the counterfeit Uni-Gold ™ HIV product, WHO medical device alert no. 2 of 2020.
|
name of the product |
Uni-Gold ™ HIV |
|
Series number |
HIV7120026 |
|
expiration date |
December 5, 2020 |
|
Manufacturer specified |
Trinity Biotech |
The packaging of this counterfeit HIV test kit is in English.
The true manufacturer (Trinity Biotech plc) confirmed that:
- They did not produce counterfeit products in Table 1.
- The original HIV7120026 series was made by Trinity Biotech plc and expired in 2019.
- The expiration date is incorrect and does not match their batch production record.
Photos and tips for the public are available below.
Figure 1 – Counterfeit Uni-Gold ™ HIV, serial number HIV7120026, showing counterfeit expiration date
Figure 2 – Counterfeit Uni-Gold ™ HIV, showing labeling inconsistencies
Tips for actions end-users need to take:
- Please check that the Uni-Gold ™ HIV Test Test in your facility has the serial number HIV7120026.
- If you own these counterfeit test kits with serial number HIV7120026:
- Please do not use.
- Please contact the organization that delivered the product to you immediately (be it an HIV testing program, an NGO, or a local distributor).
- Please contact Trinity Biotech plc
Phone: +353 1 276 9800
E-mail: [email protected]
- Please contact the national health authorities
All medical products must be obtained from credible and reliable sources. Their authenticity and condition should be carefully checked.
Advice on action to be taken by national health authorities:
WHO requires increased control in the supply chains of all countries, especially at testing sites (health facilities, in the community), clinical laboratories, medical stores / warehouses and at facilities of relevant economic agents (agents,
authorized dealers, distributors, wholesalers, etc.).
If these counterfeit test kits with serial number HIV7120026 are detected, do not use them.
National health authorities ask you to notify WHO immediately if any counterfeit products in their country are being used Appeal form Who is IVD.
If you have any information on the production, distribution or supply of this product, please contact [email protected]
WHO Global Surveillance and Surveillance System for substandard and counterfeit medical products
For more information, visit our website: https://www.who.int/medicines/regulation/ssffc/en/
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