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FDA Warns Against Expired Malaria Test Kit SD Bio Line

The Food and Drugs Authority (FDA) has warned the public against the presence of an expired Malaria Rapid Diagnostic Test (RDT) on the Ghanaian market.

According to the FDA, its investigations have uncovered that even though the product has been approved, some individuals have tampered with the product information on it.

“The Food and Drugs Authority (FDA) wishes to alert the general public of an expired malaria Rapid Diagnostic Test (RDT) kit being offered for sale on the Ghanaian market. The FDA has investigated a complaint and established the fact that some persons have tampered with the product information on the said expired kit,” the statement said.

It added: “Though the said kit, SD Bio Line Malaria Test Kit, has been registered by the FDA, investigation has revealed that the following information has been used to re-label the expired product: Lot No.: 05CDC017A Mfg. Date: 2018-03-09 Exi:L Date: 2020-03-08 Code: B303D . In view of the recent experience with resistance of the malaria parasite to treatment, the current policy on treatment of malaria in Ghana requires that every suspected case of malaria is tested before treatment. It is, therefore, 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. 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”.

The statement further urged health professional to notify the FDA of any expired product in their facilities for safe disposal.

“Additionally, healthcare professionals are reminded to notify the FDA of any expired products in their facilities for safe disposal. 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”.

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