HSA has announced that Flowflex and SD Biosensor supplied in Singapore is not affected by US FDA advisory on unauthorised versions
In late 2021, when FlowFlex became one of the first few brands that have achieved FDA EUA, traders in Europe illegally exported around 200,000 European approved tests to the USA. The European packaging differs from the USA version. In addition, doing so puts US consumers at risk of dated stocks and uncontrolled medical device supply chain. The FDA ordered a recall of this specific batch of 200,000 European tests from the US market to protect the US consumers.
This recall pertains to rectifying the illegal imports from Europe to the USA. Product quality has not been the reason for this recall. The Singapore HSA approved version differs from both the US and Europe version and is not affected by this recall.
The FDA safety communication is meant for the US audience only. It serves to remind US consumers to avoid using the 'dark blue box' which is the design of the box used outside the USA. The recalled product was the European version and they are in dark blue. Fortunately, the HSA version shares a similar dark blue but not identical design. The HSA version includes the name of the PSAR holder Alcotech Pte. Ltd. For this reason, the safety communication issued by FDA does not affect FlowFlex ART in Singapore.
You may view HSA's statement at the following links