The recall of Flowflex SARS-CoV-2 Antigen Rapid Test (ART) self-testing kits from the ACON Laboratories does not affect those sold in the Sultanate as they are from Europe and not the United States (US), said Permanent Secretary at the Ministry of Health (MoH) Haji Maswadi bin Haji Mohsin at a daily press conference yesterday.
“The issue raised by the US Food and Drug Administration (FDA) is that the kits are sold illegally on the US market. Any ART kit products sold on that market must be approved by the US FDA,” said the permanent secretary.
The permanent secretary explained that the Flowflex ART kit sold in Brunei has the CE mark that has obtained approval from the European market, much like other goods sold in Brunei that have the same CE mark.
He also said the kits have been tested and approved by the MoH. The permanent secretary said the Flowflex ART kit approved for the US market is sold in a white box, whereas the ART kit approved for the European market with the CE mark is boxed in blue. He also cited a statement from ACON Laboratories that the recall of Flowflex ART kits was due to the European kits not approved for import into the US market.