The Food and Drugs Authority (FDA) has issued an urgent public safety alert following the discovery of falsified VISITECT CD4 Advanced Disease test kits in circulation, warning healthcare providers and patients that the counterfeit products could lead to misdiagnosis, delayed treatment, and serious health consequences.

According to the alert released by the regulator, the bogus diagnostic kits bear lot number 0001586 and falsely list Omega Diagnostics Limited of the United Kingdom as the manufacturer. 

The genuine product, by contrast, is manufactured by AccuBio Limited—also of the UK—with lot number 0002172 and a different instructions-for-use version number.

How to spot the fake

The authentic VISITECT CD4 Advanced Disease test kit carries a manufacturing date of July 2025 and expires in November 2026. The falsified version, with lot number 0001586, lists a manufacturing date of August 2024 and an expiry date of January 2027, while incorrectly claiming to be produced by Omega Diagnostics.

The red flag, the FDA noted, is immediately obvious when comparing the manufacturer details side by side. The counterfeit product names a different manufacturer altogether—a discrepancy that should trigger immediate suspicion.

The dangers of falsified medical products

The authority warned that using falsified medical products is not a minor infraction but a serious public health threat. Such products can lead to wrong test results, which in turn can cause delayed treatment for patients who may be living with HIV, or unnecessary anxiety for those who receive false positives. In either scenario, the consequences can be life-altering.

"Your health is too important to risk," the alert read, urging all users to verify diagnostic products before use.

What healthcare providers must do

The FDA has directed all health facilities, laboratories, and testing centres to immediately check their stocks of VISITECT HIV Advanced Disease test kits. Any kits bearing lot number 0001586 must be ceased from use without delay.

Affected kits are to be returned to the nearest FDA office for safe disposal. The authority has also encouraged healthcare providers and members of the public to contact the FDA directly on 0551112224 or 0244310297 for further guidance or to report suspected falsified products.

Broader issue

The discovery of counterfeit HIV test kits adds to a growing list of falsified medical products that have infiltrated the Ghanaian market in recent years, from fake malaria drugs to substandard antibiotics. The FDA has repeatedly warned that criminal networks are exploiting weak supply chain controls to peddle dangerous imitations that put lives at risk.

For patients living with HIV, accurate CD4 testing is critical for monitoring disease progression and determining when to initiate or switch antiretroviral therapy. A falsified test kit that produces inaccurate results could mean the difference between life-saving treatment and catastrophic treatment failure.

The FDA has assured the public that investigations are ongoing to determine the source of the counterfeit kits and to apprehend those responsible. In the meantime, the authority has urged vigilance at every point of care.

"Always verify before use," the alert concluded.