The AOF proceeded with the recall of the diagnostic test kit (rapid test) after inspections carried out by the National Transparency Authority. In particular, as mentioned in a relevant announcement of the National Transparency Authority, the inspection was carried out following a complaint, in Thessaloniki, in two branches of a private company providing diagnostic tests for rapid antigen detection of SARS-CoV-2 virus (rapid test), regarding its legality its operation and the services it provides.
The inspection revealed, inter alia, the use of a specific medical device (rapid test kit), which did not bear the special CE marking and therefore did not meet the requirements of compliance with the European Commission’s medical device use directives (Directive 98 /79/Ε.Κ.).
The auditors-inspectors of the National Transparency Authority communicated the findings of the audit to the competent supervisory authorities, with the result that the AEO recalled the specific product from the market for reasons of public health protection.
“Checks on the legality of conducting and registering SARS-CoV-2 rapid antigen diagnostic tests (rapid test) continue throughout the country on the basis of complaints and ex-officio checks of the competent control and supervisory authorities,” the statement said.
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Source From: Capital
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