Food and Drugs Authority (FDA) has issued a warning following the discovery of counterfeit HIV diagnostic test kits that pose a threat of misinformation for test results and delays in treatment, especially for the already immunocompromised in Ghana.
The Authority specifically identified VISITECT CD4 Advanced Disease test kits with lot number 0001586 as impacted, detailing them to be counterfeit and non-compliant with international standards. While the fake kits fraudulently state they are made by Omega Diagnostics Limited, genuine VISITECT CD4 test kits are produced by AccuBio Limited, carry the lot number 0002172, and the correct product information.
Additionally, the FDA cited significant discrepancies between the manufacturing and expiry dates printed on the fake and original products.The counterfeit items boast a manufacturing date of August 2024, expiring in January 2027. The actual product however, was manufactured in July 2025 and is set to expire in November 2026. Any disparities in dates and manufacturer information on medical items must serve as warning signs to health practitioners, the Authority warned.
The Authority had declared fake HIV test kits pose serious public health risk and emphasized on accuracy testing in HIV management with dire health consequences of any slip-up. The Health Ministry has further warned fake findings that may bring to the surface unwanted fear among the infected through false positive result or delay of treatment to HIV patients.
“Your health is too important to risk,” warned the FDA, calling upon healthcare service providers to exercise a higher sense of caution. As part of urgent action plan, the Authority had directed all hospitals, clinics, laboratories and testing points to assess their stock of VISITECT CD4 test kits and remove any kit with Lot Number 0001586 from use with immediate effect.
The Authority further directed that such items be brought to the nearest FDA field offices for their proper disposal and asked that the general public as well as healthcare providers utilize FDA official channels to report to it if they see any such fake medical products. The Health Ministry, while indicating that investigations into the sources of the fake kits and its culprits were ongoing; it cautioned the public against the use of any medical products without thorough examination prior to their use.
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