Disposable swab withdrawn from the Portuguese market

Deepak Gupta August 19, 2022
Updated 2022/08/19 at 5:48 PM

If the term swab was unknown to many, with the COVID-19 pandemic it became a word used very often. In practice, a swab allows the collection of samples to later analyze whether the person is infected.

In Portugal, a disposable swab was withdrawn from the market for improperly bearing the CE mark.

Infarmed ordered the suspension of marketing today and the withdrawal of a disposable swab for collection of samples, from the Iclean brand, for improperly bearing the CE mark, as there is no evidence of compliance with European legal requirements.

According to the health authority, at stake is the fact that the product is improperly qualified by the manufacturer as an “in vitro diagnostic medical device”when the appropriate qualification is that of a medical device.

Consequently, there is no evidence that the device has been subject to the respective conformity assessment by an evaluative Notified Body, namely the aspects related to obtaining, guaranteeing and maintaining the sterility conditions

It is the model “Nasopharyngeal Swab Flocked” from the “iclean” brand, from the manufacturer Shenzhen Cleanmo Technology.

According to the National Authority for Medicines and Health Products, the distributor - Vacuette Portugal SA - is “developing the necessary actions for the collection of said medical device”.

Disposable swab withdrawn from the Portuguese market

Infarmed also says that entities that have units of this medical device should not make it available/use it.

Infarmet: a ban was also Monkeypox Quick Test

The placing on the market of the “Quick Test Monkeypox”, by the manufacturer Pantest, was also prohibited, due to non-compliance with the conditions required for its availability. In an informative circular published on the website, Infarmed states that, by deliberation dated 11 August, it prohibited the placing on the market of the medical device for 'in vitro' diagnosis "Monkeypox Ag Pantest rapid test (Reference MKP(AG))" , under Directive 98/79/EC.

Portugal registers 810 confirmed cases of Monkeypox, according to data from the Directorate-General for Health released on Thursday.

On July 16, vaccination of the first close contacts of infected people began, and by August 13, 215 contacts were vaccinated.

The DGS states that eligible contacts in the different regions continue to be identified and oriented towards vaccination.

According to the DGS, Portugal remains on the list of the 10 countries with the most infections, being the sixth European country with the highest incidence.

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