Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.586 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens CC 20-01 - ADVIA Centaur NT-proBNP (PBNP) Assay kit
Siemens Healthcare Diagnostics Inc. confirmed an average method comparison bias of up to 20% with ADVIA Centaur NT-proBNP (PBNP) ...
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Leonhard Lang GmbH RKL-4453 (GS ref.: VGL-15814) - GS defibrillation electrodes
In the course of an investigation triggered by a complaint, it was discovered that there is a possible contact problem between ...
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Datex-Ohmeda, FMI 34104, Carestation 600 Series
GE Healthcare heeft kennisgenomen van een mogelijkheid dat er een losse kabelaansluiting kan voorkomen binnenin specifieke ...
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Fresenius Medical Care AG & Co. KGaA SO-2019-2857 - PatientOnLine
As part of our continuous quality assurance process it was identified that the used method of APEX ( Accelerated Peritonea! ...
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Datascope Corp. Getinge 2248146-11-03-2019-003-R-NL - Maquet Reinforced Introducer Set
During the execution of a remediation protocol for re-verification of packaging, Datascope / Maquet Getinge found a small slit on ...
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B.Braun Melsungen, RECALL 2019-12-13 STK/AS, Original-Perfusor Leitung PCA
Gedurende post-market surveillance activiteiten hebben we ontdekt dat er tussen de lijn en de Y-connector in sommige gevallen ...
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Wallac Oy, R2019003, GSP Neonatal IRT kit
External quality assurance e.g. proficiency test samples may contain citrate or EDTA and therefore the measured IRT analyte ...
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FCI S.A.S. FSCA N° 19-002 - Purified silicone oil
Due to the lack of lubrication of the stopper, we have noticed a strong adherence to the inner wall can occur. lt may also twist ...
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Biomet France, ZFA-2019-00325, Optipac
Er zijn een aantal kleurvariaties van de steriele stip (verschillende tinten groen) gerapporteerd.
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Medtronic Navigation Inc. FA895 - O-arm™ O2 Imaging System
Medtronic has determined through internal testing that there is a potential for navigational inaccuracy when utilizing the ...