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Izah Azahari
The recall of Flowflex SARS-CoV-2 Antigen Speedy Check (ART) self-testing kits from the ACON Laboratories doesn’t have an effect on these offered within the Sultanate as they’re from Europe and never the US (US), stated Everlasting Secretary on the Ministry of Well being (MoH) Haji Maswadi bin Haji Mohsin at a every day press convention yesterday.
“The difficulty raised by the US Meals and Drug Administration (FDA) is that the kits are offered illegally on the US market. Any ART equipment merchandise offered on that market have to be accepted by the US FDA,” stated the everlasting secretary.
The everlasting secretary defined that the Flowflex ART equipment offered in Brunei has the CE mark that has obtained approval from the European market, very like different items offered in Brunei which have the identical CE mark.
He additionally stated the kits have been examined and accepted by the MoH. The everlasting secretary stated the Flowflex ART equipment accepted for the US market is offered in a white field, whereas the ART equipment accepted for the European market with the CE mark is boxed in blue. He additionally cited an announcement from ACON Laboratories that the recall of Flowflex ART kits was as a result of European kits not accepted for import into the US market.
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