Covid-19 test kit not withdrawn on safety grounds, says importer

Covid-19 test kit not withdrawn on safety grounds, says importer

Conan Medical Technology Bhd says the cancellation of the conditional approval was due to the failure in report submission.

Conan Medical Technology Bhd says the cancellation of the approval for its Xiamen Wiz Biotech SARS-CoV-2 antigen rapid test kit has no relation to the quality, safety and performance of the product.
PETALING JAYA:
The importer of a Covid-19 self-test kit suspended recently says the cancellation of the conditional approval by the health ministry has nothing to do with safety reasons.

The suspension by the health ministry’s Medical Device Authority (MDA) involved nasal swab tests from Xiamen Wiz Biotech Co Ltd, distributed locally by Conan Medical Technology Bhd.

MDA had also revoked the approval for the saliva test kit manufactured by Anhui Deepblue Medical Technology Co Ltd, distributed locally by Innovac Technology.

In a statement, Conan Medical Technology said the cancellation of the conditional approval was due to its failure in report submission.

It said the cancellation had no relation to the quality, safety and performance of the product.

“The Wiz Biotech SARS-CoV-2 antigen rapid test kit passed an evaluation test at Universiti Malaya on Oct 5, 2021 and successfully obtained conditional approval on Oct 26.

“We affirm that all stocks in the market are from the same batch evaluated and approved with no change to the quality of the product.”

Conan Medical Technology added that it would resolve the matter soon.

“We are resolving the administrative issue with MDA and will rectify our administrative shortcoming as soon as possible.

“We apologise for our shortcomings, and request our distributors, sellers, customers and members of the public to remain calm,” it said.

Earlier this week, MDA revoked the conditional approval given to two Covid-19 self-test kit manufacturers, effective immediately.

It said the two companies had failed to comply with the conditions of approval given by the agency.

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