FDA issues safety alert over falsified Visitect HIV Advanced Disease Test Kits found in Nigeria

Nii Ayitey Brown 04:43 - 07 April 2026

The FDA has issued a safety alert after falsified and unregistered VISITECT HIV Advanced Disease Test Kits were found in Nigeria. The affected kits carry Lot Number 0001586. The public and health facilities are advised to stop using them, return them to the FDA, and report any adverse reactions. The FDA has stepped up surveillance to remove the fake products from circulation.

The Food and Drugs Authority (FDA) has issued a public safety alert after falsified and unregistered versions of the VISITECT HIV Advanced Disease Test Kits were detected circulating in Nigeria.

According to the Authority, the counterfeit products—which have also been parallel imported—are not registered for use in Ghana and are being distributed through unauthorised supply channels.

Details of the Falsified Test Kits

The FDA shared a side-by-side comparison of the genuine, registered VISITECT CD4 Advanced Disease Test Kits and the falsified versions currently identified:

Parameter

Genuine (Registered) Version

Falsified (Unregistered) Version

Product Name

VISITECT CD4 Advanced Disease Test Kits

Manufacturer

AccuBio Ltd, Units 1–12 Hillfoots Business Village, Alva, FK12 5DQ, Scotland, UK

Omega Diagnostics Ltd, Omega House, Hillfoots Business Village, Alva, FK12 5DQ, Scotland, UK

Lot Number

0002172

0001586

IFU Version

Manufacturing Date

2025-07

202408

Expiry Date

2026-11

202701

Euro Specs International Nigeria Limited, the Marketing Authorisation Holder (MAH), has confirmed the presence of these falsified and unregistered versions in circulation.

What the Visitect HIV Advanced Disease Test Kit Does

The Visitect HIV Advanced Disease Test Kit is a rapid, instrument-free lateral flow device used to identify patients with severe HIV infection—specifically those with CD4 counts below 200 cells/µL. The test produces results within 40 minutes using blood samples and is officially registered for use in Ghana.

The FDA warns that falsified, unlicensed, and unregistered medical products can lead to dangerous consequences including toxicity, treatment failure, and even death.

Advice to the Public and Health Professionals

The FDA is urging the public and healthcare practitioners to take the following actions immediately:

Inspect all Visitect HIV Advanced Disease Test Kits in their possession and stop using any kits with Lot Number 0001586.
Return all affected kits to the nearest FDA office for safe disposal.
Seek clarification or report suspicious products via:
- Mobile: 024 431 0297 / 055 111 2224
- Email: drug.safety@fda.gov.gh

FDA’s Response

The Authority has intensified post-market surveillance activities across Ghana’s borders and health facilities to identify and remove the affected batches from circulation.

Reporting Adverse Reactions

The FDA is encouraging the public, especially healthcare providers, to report any adverse reactions or suspected substandard or falsified medical devices through any of these channels:

Download and complete the Med Safety App (available on Google Play Store and App Store)
Submit a report online at: http://adr.fdaghana.gov.gh/patient.php
Call 024 4310 297 or the FDA Hotline: 0308 250 070
Complete the Adverse Reaction Reporting Form and submit it at the nearest health facility

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