Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Siemens Healthcare Diagnostics Products GmbH, PH-23-001-A-C, Test Thrombin Reagent
Siemens Healthcare Diagnostics Products GmbH received complaints regarding control recovery issues for Test Thrombin Reagent kit ...
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Beckman Coulter, Inc., FSN-FA 23021, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter heeft vastgesteld dat de hierboven vermelde softwareversie van de DxI 9000 Access-immunoassay-analyser het aantal ...
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Siemens Healthcare Diagnostics Inc, ACHC 23-03, Atellica CH Toxicology Calibrator
Siemens Healthcare Diagnostics Inc. received customer complaints regarding a positive bias for the Atellica CH Salicylate (Sal) ...
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RAL Diagnostics, NC 23.042, Buffer solutions for automated systems
De gebruiker heeft bacteriën gevonden in bloeduitstrijkjes en er werden intern klachten van klanten gemeld.
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ROCAMED France,FSCA-03-2023-1,Urology suction tubing with pump body
ROCAMED SAM has received complaints about Urology Suction Tubing with Pump Body of reference SOUR9200ST12 of lot R006497. The ...
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Siemens Healthcare Diagnostics, AIMC 23-07, Atellica IM Cortisol, ADVIA Centaur Cortisol
Atellica IM and ADVIA Centaur Systems Urine Cortisol Negative Bias
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William A. Cook Australia Pty Ltd, 2023FA0004/QCR-2023-04, Zenith Branch Endovascular Graft and Bifurcated Iliac Sidebranch Endovascular Graft
William A. Cook Australië heeft meldingen ontvangen over het feit dat de kathetertip, een onderdeel van het Zenith® Branch ...
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Helena Biosciences Europe, FSN-NC661, Collagen
This lot of Collagen has demonstrated poor aggregation response at very low doses of 1.25ug/mL
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Thermo Fisher Scientific, FSN-2023-001, Thermo Scientific Oxoid MacConkey Agar wout Salt
Continued use of this lot may result in delay to patient treatment
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One Lambda Inc, PN# 2022-0593;MDSS ref.:IVD22.022, LinkSēq™ HLA-ABCDRDQDP+ 384 Typing Kit
There is a risk of incorrect test results assigned to patient sample. Transplants require confirmatory testing derived from ...