PharmacovigilanceOfficial

BASG: Danish sperm bank blocks donor 8306/Bernt over alpha-1 antitrypsin deficiency carrier status

🇦🇹 BASG · Fri 13 Nov 2026

Austria's regulator relays a Danish notice that European Sperm Bank has blocked the donor's gametes, though use for siblings of existing donor-conceived children remains possible.

Austria's Federal Office for Safety in Health Care (BASG) published a safety information notice on 13 November 2026 about sperm donor 8306/Bernt of the Danish tissue bank European Sperm Bank. The notice sits in the authority's blood and tissue section.

According to BASG, the Danish authority told it that the tissue bank had reported the donor to be a healthy carrier of the Z variant in the SERPINA1 gene. This makes him a carrier of alpha-1 antitrypsin deficiency.

The donor and his donor gametes have been blocked. The notice adds, however, that they can still be used for sibling children. It does not say how many families, recipients or treatment centres may be affected, or in which countries the gametes were distributed.

BASG says the notice reflects its current state of knowledge and that it will publish more information when it becomes available. Enquiries can go to the authority's tissue vigilance mailbox, gewebevigilanz@basg.gv.at, or directly to the tissue bank that supplied the donation. A short PDF accompanies the notice.

What it means for your team

  • Tissue and cell establishments and fertility clinics in Austria that obtained gametes from European Sperm Bank should check whether any inventory or treatments involve donor 8306/Bernt.
  • The block is not absolute: the notice allows continued use for sibling children, so the restriction needs to be applied correctly in donor-allocation and traceability records.
  • Quality and vigilance teams should watch for BASG updates and use the tissue vigilance contact for questions, as the notice gives no further detail on scope.

Official source: BASG ↗

Article written by VigiEye from the official source (BASG). AI-assisted; check the source before acting.

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