Blood & tissue
Cryos International-Aarhus - Donor VIND
Safety warnings
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Blood & Tissue
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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
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Information about the medical device FQE614B (Macopharma)
Safety warnings
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Blood & Tissue
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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)
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Update: West Nile Virus (WNV) - Non EU countries
Safety warnings
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Blood & Tissue
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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
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European Sperm Bank - Donor-25006 ARNI
Safety warnings
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Blood & Tissue
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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
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SellmerDiers Spermbank - Donor BENTON
Safety warnings
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Blood & Tissue
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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
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Cryos International - Donor SPECTRE
Safety warnings
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Blood & Tissue
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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
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Denu tips and aspiration needles
Recall
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Blood & Tissue
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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
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Grafton DBM
Recall
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Blood & Tissue
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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
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European Sperm Bank – donor-25203 MUGGIE
Safety warnings
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Blood & Tissue
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27/12/2022
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 male offspring of donor-25203 MUGGIE-has been diagnosed with global developmental delay, decreased liver function, and abnormal glycosylation.
European Sperm Bank – donor-25203 MUGGIE
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European Sperm Bank - Donor-8989 JOAO
Safety warnings
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Blood & Tissue
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27/12/2022
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 an offspring of donor-8989 JOAO was diagnosed with phenylketonuria (PKU) during routine newborn screening.
European Sperm Bank - Donor-8989 JOAO
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