Official announcements
Recall
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Medicines
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21/08/2023
Recall due to contamination with salbutamol
messages in brief
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21/08/2023
On Friday 18.8.2023 a delegation of the Chinese Drug Administration Zhejiang Medical Products Administration visited the AGES Medical Market Surveillance for an exchange and deeper insights into the fields of activity.
Safety warnings
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Blood & Tissue
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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.
Recall
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Medicines
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18/08/2023
Recall due to possible particles
Recall
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Medicines
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17/08/2023
Recall due to slightly increased peroxide number
Safety warnings
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Blood & Tissue
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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.
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.
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.
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.
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.