Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens ASI 19-02 - Atellica® Solution
Siemens Healthcare Diagnostics, Inc. has confirmed that the Atellica CH 930 Analyzer may report incorrect serum indices for ...
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Becton Dickinson BDDS-19-1617 - BD Kiestra™ InoqulA+™ TLA
Op basis van klantenfeedback stelde BD vast dat een softwareprobleem onder specifieke omstandigheden een mismatch zou kunnen ...
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BioFire Diagnostics, LLC - FSCA 4280-1 - FilmArray® Gastrointestinal (GI) Panel
Update van het onderzoek Een verhoogde incidentie van niet-specifieke chemische interacties in BioFire GI-panels, uitgevoerd op ...
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QIAGEN GmbH - CI-MAN-2019-003 - QIAsymphony SP
Wanneer een run met meerdere batches wordt uitgevoerd met gebruik van continu laden in combinatie met de integratiefunctie voor ...
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Roche Diagnostics GmbH- CN-437494 - Elecsys Anti-CCP
We wish to inform you that Roche has received a number of reports of performance issues with certain lots of the Elecsys Anti-CCP ...
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Hitachi High-Technologies Corporation (HHT) - IO-0000164 - Cobas diverse modellen
We were recently informed by the manufacturer Hitachi High Technologies (HHT) about a quality issue with high pressure solenoid ...
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Roche Diagnostics GmbH - CN-454518 - cobas t 511 coagulation analyzer, cobas t 711 coagulation analyzer
This FSN is relevant only for cobas t 711 and cobas t 511 coagulation analyzers already installed at customer sites, or in case ...
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Hologic FA-00095 - Aptima Combo 2 Assay
Genetic variants are a natural by-product of microbial evolution and a new Chlamydia trachomatis (CT) variant has been identified ...
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Abbott Diagnostics FA21MAY2019 - Alinity ci-series System Control Module
Abbott has identified an issue with all on-market versions of Alinity ci-series software where the software may not detect an ...
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Luminex Molecualr Diagnostics, Inc - RC-18-012 - xTAG® Gastrointestinal Pathogen Panel (GPP)
We have received customer complaints regarding xTAG® Gastrointestinal Pathogen Panel (GPP) reporting lower MS2 MFI values. ...