Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.325 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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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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DiaSys Diagnostic Systems NCR 22-46 - HDL-c direct FS
During internal control measurements, a carryover effect of Bilirubin Auto Total FS into HDL-c direct FS was discovered on the ...
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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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MAQUET SAS, FSN-MSA-605552, Volista STANDOP
Under certain conditions, it was established that the paint could chip on a specific part of the fork. Therefore, there is a risk ...
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3M Deutschland GmbH, FSN-2022-04 FSCA ColdHot, 3M Nexcare™ ColdHot Therapy pack
Een partij van het referentieproduct N1570G was verpakt in verzenddozen die ten onrechte waren geëtiketteerd als referentie ...
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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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Waters Corporation 1218959-10_08_2021-001-C - Xevo TQ-S, TQD, TQ-S Micro and TQ-XS
Na onderzoek is een kwetsbaarheid gevonden in de NeoLynx- of IonLynx-verwerkingsbrowser waar bij het uiteindelijke monster van ...
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Cook Incorporated, FSN-2022FA0001, Hilal Embolization Microcoil, Nester® Embolization Microcoil, Tornado® Embolization Microcoil
During manufacturing, Cook Medical identified that the loading cartridge included with Hilal Embolization Microcoils, Nester® ...
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Becton, Dickinson and Company, BD Biosciences, FSN-BDB-22-4384a, BD™ Anti-Kappa (TB28-2) APC, BD™ Anti-Kappa (TB28-2) PE
Becton Dickinson determined through internal investigation that a common material lot used to manufacture the affected products ...