Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Agilent Technologies CAPA00415 - AriaDx/Mx Real-Time PCR Instrument
Agilent is op de hoogte gebracht van een incident met betrekking tot het AriaDx Real-Time PCR-systeem waarbij de onbewerkte ...
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bioMérieux FSCA 5690 - NUCLISENS® easyMAG® Magnetic Silica
Following complaints from the field for contamination observed on extraction reagents with Legionella spp nucleic acids using ...
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Roche Diagnostics CN-596638 - VENTANA HE 600 System
Roche has confirmed 2 complaints regarding fluid leaks within the middle stainer module of the VENTANA HE 600 that likely ...
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Thermo Fisher Scientific, FSN-2022-006, Thermo Scientific IDEIA Lyme Neuroborreliosis
An internal technical investigation has determined that when testing at 20°C, K602811-2 IDEIA Lyme Neuroborreliosis Lots. ...
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Qlife Aps, 18885, Egoo SARS-CoV-2 Capsule
An empty or partly empty capsules was identifed for Egoo SAS-CoV-2 Capsule. An empty capsule can provide a false negative result ...
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Actim Oy, 454, Actim Partus 1ngeni
Internal quality control has found that due to an error in the test cassette QR code,the quantitative results will give a false ...
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Abbott GmbH FA09JUN2022 - ARCHITECT and Alinity c Hemoglobin A1c (Reagent Kit)
This letter is to inform you of a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c patient results to be ...
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Menarini Silicon Biosystems Inc., FSN-3004153557-05/20/2022-001-C, CELLSEARCH® Circulating Tumor Cell Kits
Hoog aantal totale beelden/niet-toegewezen voorvallen (inclusief dubbele positieven) en de mogelijkheid dat vals-positieve ...
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Leica Biosystems Nussloch GmbH, FSN-NCMR: 200100198, Leica Biosystems Tissue processor, HistoCore SPECTRA ST
As part of our post market surveillance, we have identified 7 vulnerabilities affecting the PTC (Parametric Technology ...
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Actim Oy FSCA 471 - Actim Partus 1ngeni
Our long-term stability testing has shown that the quantitative results of Actim Partus 1ngeni do not fulfill the acceptance ...