Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.594 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Cepheid, FSN-21FAR005, Xpert BCR/ABL Ultra
Cepheid heeft recentelijk geconstateerd dat er twee batches van Xpert® BCR-ABL Ultra foutieve resultaten rapporteren die in ...
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Randox Laboratories Ltd, FSN-REC509, Randox Calibration Serum Level 3
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using ...
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NuVasive, Inc., FSN-MAGEC-3, MAGEC System
NuVasive Specialized Orthopedics (NSO) received notification from DQS Medizinprodukte GmbH (DQS), its notified body, that the CE ...
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Wilson-Cook Medical, Inc., FSN-2021FA0003, Hemospray Endoscopic Hemostat
Urgent Field Safety Notice Hemospray Endoscopic Hemostat.
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Fuji Systems Corporation, Shirakawa Plant, FSN-FSCA-2021- 01, Sterilized Drape for PDE
Urgent Field Safety Notice Sterilized Drape for PDE.
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Siemens Healthcare Diagnostics Inc, FSN-CHI 21-01, ADVIA Chemistry System
Siemens Healthcare Diagnostics has identified the following issues with the ADVIA Chemistry products.
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M.E.D. Medical Products GmbH, FSN-21-1, Sterile Customer Kits Manufactured by M.E.D. Medical Products that contain BD components
This letter indicates that the supplier Becton Dickinson has issued a safety notice with regard to syringes and needles (see ...
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Microport CRM B.V. CRM-CLA-2021-001 - Symphony en Rhapsody pacemakers
Risico op onjuiste patiënt controle als gevolg van de vertraagde follow-up van een patiënt bij wie een eerdere generatie ...
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Torunskie Zaldadv Materialów Ooatrunkowvch SA, FSN-RI/31.03.2021, MATOSET
Urgent Field Safety MATOSET.
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Radiometer Medical ApS., FSN-FAN 915-416, ABL90 FLEX analyzer, ABL90 FLEX PLUS analyzer
Radiometer has become aware of a potential issue with ABL90 FLEX and ABL90 FLEX PLUS analyzers.