Belgian’s federal agency for medicines and health products (FAMHP) takes IClean swabs of the market.
On July 23 2020, the federal agency for medicines and health products found non-conformity’s with the nasopharyngeal swabs of the brand IClean. They did not meet the required CE standards for a Class I S medical device. The decision was made to prohibit the sale and usage of these swabs on the Belgian territory.
1. Loss of the nylon flocks
The downside on flocked swabs is the fact that poorly produced swabs lose their nylon particles. Those particles stay in the patients body and can cause serious damage.
The Iclean swab shows a tremendous loss of those particles
2. Residue in the reagent tube
Not only did it show that those swabs lose the flock particles in the patient body, but also when the specimen is taken and put in the reagent tube, particles still keep coming of.
3. Even sealed swabs have particles
It appeared that not only the used swabs showed loss in particles but even during the manufacturing process it went wrong. Loose particles within the sealed package and even in the glue of the seals were present.
