MDA revokes conditional approval for 2 Covid Self-Test Kit

As of 11th April, the Medical Device Authority (MDA) of Malaysia has announced on Facebook that the conditional approval licenses for two brands of the Rapid self-test kit have been revoked, effectively immediately.

As of 11th April, the Medical Device Authority (MDA) of Malaysia has announced on Facebook that the conditional approval licenses for two brands of the Rapid self-test kit have been revoked, effectively immediately.

The two revoked brands are:

1. COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold)-Saliva

deepblue revoked test kit

Manufacturer: Anhui Deepblue Medical Technology Co., Ltd.P.R China
Importer: Innovac Technology Sdn. Bhd

wiz biotech revoked test kit

2. Wiz Biotech SARS-CoV-2 Antigen Rapid Test (Nasal swab)

Manufacturer: Xiamen Wiz Biotech Co. Ltd., P.R.China
Importer: Conan Medical Technology Berhad

The reason for the revocation is because MDA has found that the above 2 tests do not comply with MDA requirements for fear of being unsafe for use. MDA has also stated that users do not purchase the above test kits, and if you have them in stock, please do not use them as the results may not be accurate.

Please check out our full list of other MDA approved Self-test kits

11 april mda revoked 2 test kit conditional approval