29.03.2021
To the attention of importers and distributors of PCR tests and COVID-19 testing centers
The National Agency for Medicines and Medical Devices in Romania warns all importers and distributors of PCR tests as well as COVID-19 testing centers that falsified PCR tests for COVID-19 detection, batch 04/2020, item 0097654236, manufactured by SHENZHEN PHARMACEUTICAL CO. LTD., China, have been detected on the EU market.
If you have come into possession of these products, accompanied by the document ”EC-Declaration of Conformity for CE-Marking accordion to Council Directive 98/79/EEC” which would have been issued by TUV Rheinland LGA Products GmbH, Germany, which states:
Declaration of conformity: Detection Test for Coronavirus disease 2020
COVID-19 PCR RAPID TEST
GIVD CODE: 28.08.36.91
The validity with the date of issue.
August 28, 2020
with the CE 0373 marking visible on the plastic cover of the collection swab, do not use them and notify the National Agency for Medicines and Medical Devices of Romania – the Market Surveillance Service.
To prevent the entry into the legal distribution chain, especially in the context of the COVID-19 pandemic, of non-compliant medical devices, which do not comply with applicable regulatory requirements, please exercise extra caution, permanently check the website of the National Agency for Medicines and Medical Devices of Romania for such notices and make sure that the products you purchase come from distributors approved by our institution, in line with the provisions of Art. 926 of Law 95/2006 on healthcare reform, republished, as further amended and supplemented.