The Medical Device Authority (MDA) has revoked authorization for two brands of Covid-19 self-test kits after finding their performance to be below par.
According to Health Minister Khairy Jamaluddin today, the MDA has tested 22 test kits on the market so far after receiving complaints from the public.
“So far, the results for 12 of them have been obtained and it has been found that two of them did not reach the required performance. Authorisation for both kits has been revoked immediately,” he said on Twitter today.
The two affected brands are the Wizblue brand manufactured by Anhui Deepblue Medical Technology Co, and the Wizbiotech brand manufactured by Xiamen Wiz Biotech Co, both based in China.
They were registered in Malaysia by Innovac Technology Sdn Bhd and Conan Medical Technology Bhd, respectively.
Saya telah menerima beberapa aduan berkenaan kit ujian kendiri COVID-19 yang ada di pasaran. MDA telah menguji 22 jenama. Setakat ini, 12 keputusan telah diperolehi dan mendapati 2 kit tidak mencapai tahap prestasi yang ditetapkan. Kelulusan 2 kit ini digantung serta-merta. pic.twitter.com/svwbHNRcKv
— Khairy Jamaluddin (@Khairykj) April 11, 2022
The MDA’s website currently shows there are 128 Covid-19 self-test kit brands that have been conditionally approved for the Malaysian market. The entry for the two recently rejected kits appears to have already been removed.
On Feb 17, Khairy had announced he has ordered the MDA to investigate public complaints about Covid-19 self-test kits showing dubious results.
Prior to that, the agency had also launched an online form to solicit public complaints regarding the performance of self-test kits. - Mkini
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