Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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BioFire Diagnosticss, LLC, FSCA 5761-2, BIOFIRE FILMARRAY TORCH Base
bioMérieux heeft een verhoogd risico vastgesteld op degradatie van de voedingsingangschakelaar van de TORCH-basis. Dit verhoogde ...
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DiaMed GmbH, FSCA 003-24, ID-DiaCell I-II-III, ID-DiaCell I-II-III Asia, LISS/Coombs, Coombs Anti-IgG
We have been able to confirm an increased level of complaints and adverse events related to weak non-specific reactions when ...
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Beckman Coulter, 24033, Access HBc Ab
Beckman Coulter heeft vastgesteld dat het Access HBc Ab reagenskit lotnummer dat in de bovenstaande tabel wordt vermeld, mogelijk ...
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Beckman Coulter, 24032, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter heeft vastgesteld dat USB 2.0-kabels die worden gebruikt in de DxI 9000 Immunoassay Analyzers die in de ...
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Siemens Healthcare Diagnostics Products Ltd, IMC 24-02, IMMULITE® 2000 Anti-TG Ab
Siemens Healthineers has confirmed, through the investigation of customer complaints, the potential for falsely elevated patient ...
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Biocartis, BC-023637, IdyllaTM EGFR Mutation Test
Biocartis has identified the potential for False Positive (FP) results to be generated for the S7681 target when using the ...
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Beckman Coulter, 24024, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter heeft vastgesteld dat wanneer een DxI 9000 Access Immunoassay Analyzer is aangesloten op een Laboratory ...
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Abbott Diagnostics Technologies AS, FCA-00000294, Afinion 2
This letter is to inform you that Abbott has identified an issue related to cracks developing in an internal component (pump ...
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BioFire Diagnosticss, LLC, FSCA 5761-2, BIOFIRE FILMARRAY TORCH Base
The purpose of this letter is to update you with revised information (shown in red) of a product correction involving the ...
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Siemens Healthcare Diagnostics Inc., POC 24-015, RAPIDPoint® 500e Blood Gas System
Siemens Healthineers has identified an issue with the RAPIDPoint 500e system software version 5.3. This issue affects how the ...