FDA warns of falsified HIV test kits in circulation, urges immediate checks

The Food and Drugs Authority (FDA) has issued an urgent public health alert over the circulation of falsified HIV test kits on the Ghanaian market, warning that their use could lead to dangerous medical consequences.

The affected products have been identified as VISITECT CD4 Advanced Disease HIV test kits, which the regulator says are counterfeit and do not meet approved safety and quality standards.

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According to the FDA, the falsified kits carry lot number 0001586 and incorrectly list Omega Diagnostics Limited in the United Kingdom as the manufacturer.

In contrast, the genuine kits are produced by AccuBio Limited and come with different product specifications and identification details.

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The Authority warned that the presence of fake HIV diagnostic kits poses a serious threat to public health, particularly for patients who depend on accurate testing for timely treatment.

The counterfeit kits may produce inaccurate results, which could lead to misdiagnosis, delayed treatment, or unnecessary anxiety for patients.

Accurate CD4 testing plays a critical role in monitoring HIV progression and determining when patients should begin or adjust treatment.

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Any compromise in test results could therefore have life-threatening consequences. The FDA highlighted several discrepancies to help health professionals and the public distinguish between genuine and falsified products.

The authentic VISITECT CD4 kits were manufactured in July 2025 and are expected to expire in November 2026.

However, the counterfeit versions display different dates, showing August 2024 as the manufacturing date and January 2027 as the expiry date.

The regulator noted that inconsistencies in manufacturer details and dates should serve as clear warning signs.

As part of urgent safety measures, the FDA has directed all hospitals, laboratories and testing centres to immediately inspect their stock of HIV test kits.

Any products bearing the affected lot number have been ordered to be withdrawn from use and returned to the nearest FDA office for proper disposal.