Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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BioFire Diagnosticss, LLC, FSCA 5761-1, BIOFIRE FILMARRAY TORCH
When turning on BIOFIRE TORCH systems, arcing inside of the power switch may result in carbon build-up on the switch contacts. ...
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Illumina, Inc., FSN-QI – 00632, NextSeq 550Dx Instrument / MiSeq Dx Instrument
Illumina heeft een kwetsbaarheid in de cybersecurity aangetroffen die van toepassing is op de Local Run Manager (LRM)-software in ...
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QuidelOrtho (Ortho Clinical Diagnostics Inc), CL2023-250, ORTHO VISION and VISION Max Analyzers for BioVue
During an internal review, QuidelOrtho identified that Test ID 10023 included a calculated Rh (Anti-D or RhD) Interpretation ...
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Abbott Molecular, Inc., FA-AM-OCT2023-293, Alinity m HCV AMP Kit
Abbott has identified an increase in potential for reactive negative controls as well as separate instances of false positive ...
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Instrumentation Laboratory Co., FSCA 2023-007-C, ACL TOP Family 50 Series and ACL TOP 970 CL
Deze notificatie is bedoeld om uw laboratorium te informeren over een zeldzame potentiële monster misidentificatie onder ...
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Abbott Diagnostics Scarborough, Inc., 2023 09, ID NOW™ Instrument
Bij gebruik van de huidige versie van de ID NOW-software, versie 7.0, hebben gebruikers de mogelijkheid om de ID NOW COVID-19 ...
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Siemens Healthcare Diagnostics Inc., POC 23-018, RAPIDPOINT 500 Blood Gas System and RAPIDPOINT 500e Blood Gas System
Siemens Healthcare Diagnostics Inc. has determined that two drugs, Perhexiline Maleate and Atomoxetine Hydrochloride, may ...
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Randox Laboratories Ltd., REC692, Randox G6PDH
Randox Laboratories voert een terugroepactie uit voor G-6-PDH-reagens, catalogusnummer PD410, batch 629055. Het R2 NADP- en ...
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Waters Corporation, 1218959-09/27/2023-001-C, Waters Xevo TQ-S Micro IVD
After investigation, a design vulnerability relating to firmware of Xevo TQ-S Micro IVD has been identified that, under specific ...
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SENTINEL CH. S.p.A., 03/2023; FA02OCT2023, IRON, IRON, Alinity c Iron Reagent
It has been identified that when using the ARCHITECT and Alinity c Iron products for the lots listed above, variable results can ...