Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Abbott Laboratories, FSN-FA28APR2022_06P16-01, Alinity s System
Abbott has identified a potential issue with Alinity s System software versions 2.8.0 and prior. Abbott is releasing Alinity s ...
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Abbott GmbH, FSN-FA28APR2022_06P01-55, Alinity s HIV Ag/Ab Combo Reagent Kit
Abbott has identified a potential issue with Alinity s System software versions 2.8.0 and prior. Abbott is releasing Alinity s ...
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Abbott, FA05MAY2022, Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module
Abbott Hematology is releasing new software version 5.0 for the Alinity h-series.
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Biomedical Data Solutions FSCA 64581 - Ortho Connect
It has been identified that an end user site had attempted to perform QC on a single test using multiple QC kits. The Quality ...
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Siemens Healthcare Diagnostics PH-22-005-A-C - INNOVANCE D-Dimer Controls
The purpose of this communication is to inform you about the potential risk of allergic skin reactions in case of direct skin ...
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Ortho Clinical Diagnostics CL2022-099 - ORTHO VISION and VISION Max Analyzers
Ortho Clinical Diagnostics received complaints in which customers obtained unexpected results on their ORTHO VISION analyzer. ...
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Ortho Clinical Diagnostics CL2022-094 - ORTHO Optix Reader
Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in ...
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Instrumentation Laboratory_Werfen B.V. 2022-006-R - HemosIL ReadiPlasTin
Tot op heden hebben we 65 klachten (1 in Benelux) ontvangen van prestatieproblemen bij vier lotnummers HemosIL ReadiPlasTin. Deze ...
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Haemonetics Corporation, FSN-FSCA-FY23-02, Functional Fibrinogen Kit
Haemonetics has identified a shift in the citrated blood reference range for a normal population. Due to this shift, the ranges ...
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Instrumentation Laboratory_Werfen 2022_003 - ACL TOP 300_350_500_550 CTS
We hebben geconstateerd dat er een potentiële carryover is die kan leiden tot verhoogde kwaliteitscontrole en monsterresultaten ...