Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Abbott Molecular, FA-AM-DEC2021-262, Alinity m System
Abbott Molecular has been notified of a software issue in the Mechanica! and Thermal Test System used in the manufacturing of the ...
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Instrumentation Laboratory, FSCA-001-2021, HemosIL Liquid Anti-Xa
We hebben intern vastgesteld dat HemosIL Liquid Anti-Xa (artikelnr. 00020302601) niet voldoet aan de gelabelde aan boord ...
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Canterbury Scientific Limited, FSN-FA1, Hemoglobin F and A2 Control
This letter contains information about the "Hemoglobin F&A2 Control" material used with the G11 instrument that is supplied by ...
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Stago, FSN-RC-21-0021, STA-R MAX
FIELD SAFETY NOTICE Software version 4.06 on STA R Max®
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The Binding Site Group Limited, FSN-AE056, Freelite Human Kappa Free Kit on Roche Cobas
Positieve bias met invloed op de kwaliteitscontroles van de Freelite Human Kappa Free Kit on Roche Cobas.
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Randox Laboratories Ltd, FSN-REC509, Randox Calibration Serum Level 3
Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using ...
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Roche Diagnostics GmbH, FSN-IO-0000170 (SBN-RDS-CPS-2021-001), Anti-Xa
During internal verification studies, an interference by streptokinase was detected for the assay Anti-Xa on cobas t 511/t 711.
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Tcoag Ireland Ltd, FSN-Event-2244, Destiny Max, DT 100
This Field Safety Notice (FSN) is about a potential risk of contamination by Emicizumab - of Factor VIII assays on the Tcoag DT ...
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Siemens Healthcare Diagnostics Inc, FSN-ACHC 21-02, ADVIA and Atellica GGT reagent
The purpose of this communication is to inform you of an issue with the ADVIA and Atellica GGT reagent.
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Abbott GmbH, FSN-FA29OCT2020, ARCHITECT EBV VCA IgM Calibrator
This letter is to inform you of a Product Recall for the ARCHITECT EBV VCA IgM Calibrator lot 08159BE00.