The donor/the donor gametes have been permanently blocked.

The Federal Agency for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed autochthonous cases of Chikungunya have been reported in Bellaria-Igea Marina (province of Rimini) in Italy.

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, further confirmed autochthonous cases of chikungunya have been recorded in Landes, France.

The Federal Office for Health Safety has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed autochthonous cases of dengue fever have been recorded in the Haute-Garonne department in France.

The Italian authorities have informed the Federal Office for Safety in Health Care (BASG) that, following the lifting of seasonal measures for donor selection, two human WNV infections occurred again in Italy on 2 December. As a result, ID WNV NAT testing for blood and blood component donations has been reintroduced in the province of Naples (Campania region).

The BASG has announced that the first four modules of the European Database on Medical Devices (EUDAMED) will be mandatory to use as from 28 May 2026.

The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank European Sperm Bank ApS that the donor had been diagnosed with long QT syndrome because a pathogenic variant in the KCNQ1 gene called KCNQ1 (NM_000218.2) c.1588C>T, p.(Gln530Ter) had been identified in his DNA. The donor/gametes were permanently blocked.

Recall due to particles in the solvent

Recall due to reduced release of active pharmaceutical ingredient

The Federal Agency for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, autochthonous human WNV infections have been recorded in Seville, Spain.