Medical device for blood purification withdrawn from circulation in Ukraine

Source : 112 Ukraine

Likomed LLC discovered incorrect information entered in product declaration of conformity during unscheduled inspection
19:17, 3 January 2020

112 Agency

The State Service of Ukraine for Medicines and Drug Control removed a dangerous medical device for plasmapheresis from circulation. The press center of the State Service of medicines reports.

It is reported that during an unscheduled inspection in Likomed LLC, incorrect information was found that was entered in the declaration of conformity of the product. In particular, the document indicated that the medical device belongs to safety class I and does not require the involvement of a conformity assessment body to conduct a conformity assessment procedure and is non-sterile.

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The State Service indicated that this medical device belongs to safety class IIA and is sterile, which requires the involvement of a conformity assessment body.

In addition, other violations of the Technical Regulations were identified.

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