The FDA has investigated a complaint and established the fact that some persons have tampered with the product information on the said expired kit.
A statement issued by Mrs Delese A.A. Darko, Chief Executive Officer, FDA, said though the kit, SD Bio Line Malaria Test Kit, has been registered by the FDA, investigation has revealed that the following information had been used to re-label the expired product: Lot No.: 05CDC017A; Mfg. Date: 2018-03-09; Exp. Date: 2020-03-08; Code: B303D.
It said in view of the recent experience with resistance of the malaria parasite to treatment, the current policy on the treatment of malaria in the country requires that every suspected case of malaria is tested before treatment.
‘’It is a dangerous situation to have a test for malaria using expired RDT kit, which would certainly produce a false result and may lead to inaccurate diagnosis’’, it said.
The statement said all healthcare professionals and facilities are to take note of the above and should not use such kits, if they have them in their possession.
It said healthcare professionals are reminded to notify the FDA of any expired products in their facilities for safe disposal.
The statement said the FDA would like the general public to know that, it is taking steps to retrieve the said product from the market and also working with the security agencies to ensure the arrest of the culprits.
Member of the public can reach the FDA through the following means; hotlines: 0299802932 or 0299802933; short code: 4015 (free on all networks except GLO); WhatsApp: 0206973065; twitter: @fdaghana; and Facebook: Food and Drugs Authority, Ghana.