Blood & tissue

West Nile Virus_North Macedonia

Safety warnings | Blood & Tissue | 21/08/2023
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a confirmed human WNV infection has been recorded in Northern Macedonia, in the Skopsi region.
West Nile Virus_North Macedonia Read more

European Sperm Bank - Donor NIMA

Safety warnings | Blood & Tissue | 10/08/2023
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 that a one-year-old male offspring of the donor had been diagnosed with infantile cystinosis.
European Sperm Bank - Donor NIMA Read more

Cryos International-Aarhus - Donor VIND

Safety warnings | Blood & Tissue | 09/08/2023
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank Cryos International-Aarhus (DK257551) that a 16p13.11 duplication was detected during prenatal screening of a donor-conceived fetus.
Cryos International-Aarhus - Donor VIND Read more

Information about the medical device FQE614B (Macopharma)

Safety warnings | Blood & Tissue | 08/08/2023
The Federal Office for Safety in Health Care has been informed by the French authority that measurement deviations have occurred with the medical device for whole blood collection TAT (top and top) FQE614B (equipped with an LXT leukocyte reduction filter) from the medical device manufacturer Macopharma.
Information about the medical device FQE614B (Macopharma) Read more

Update: West Nile Virus (WNV) - Non EU countries

Safety warnings | Blood & Tissue | 07/08/2023
The Federal Office for Public Health Safety has been notified by the ECDC (European Centre for Disease Prevention and Control) that confirmed human WNV infections have been recorded in the following non-EU countries: Albania, Kosovo, Montenegro, Northern Macedonia, Serbia, and Turkey.
Update: West Nile Virus (WNV) - Non EU countries Read more

European Sperm Bank - Donor-25006 ARNI

Safety warnings | Blood & Tissue | 04/08/2023
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that a hearing impairment has occurred in an offspring of donor-25006 ARNI, suggesting a possible genetic background.
European Sperm Bank - Donor-25006 ARNI Read more

SellmerDiers Spermbank - Donor BENTON

Safety warnings | Blood & Tissue | 30/06/2023
The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank SellmerDiers Spermbank that the sperm donor BENTON had been diagnosed with multiple sclerosis.
SellmerDiers Spermbank - Donor BENTON Read more

Cryos International - Donor SPECTRE

Safety warnings | Blood & Tissue | 19/05/2023
The Federal Office for Safety in Health Care has been informed by the Danish authority that is has been informed by the Danish tissue bank Cryos International that an increased risk of bacterial growth, when using straws from the sperm donor SPECTRE cannot be excluded.
Cryos International - Donor SPECTRE Read more

Denu tips and aspiration needles

Recall | Blood & Tissue | 13/03/2023
The Federal Office for Safety in Health Care has been informed via the Maltese authority that a recall of Gynemed GmbH&Co KG products (Denu tips and aspiration needles for oocyte puncture) has occurred due to insufficient documentation of testing and control of raw material.
Denu tips and aspiration needles Read more

Grafton DBM

Recall | Blood & Tissue | 16/02/2023
The Federal Office for Safety in Health Care has been notified by the Netherlands Authority that sterility issues have occurred with Medtronic's Grafton DBM products (demineralized bone allografts).
Grafton DBM Read more
Email

Further inquiry note