Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.589 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Smith & Nephew, Inc, Endoscopy Division, FSN-R-2020-11, SUTUREFIX ULTRA 1.7MM DRILL (S)
Door middel van deze brief delen wij u mede dat Smith & Nephew, Inc. een vrijwillige terugroeping uitvoert van een partij ...
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MarDx Diagnostic, R009-20, Uni-Gold S pneumoniae
Ontoereikendheid in de gebruiksaanwijzing van het product, - gedeelte over beoogd gebruik.
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Roche Diagnostics CN-481196 - Elecsys Troponin T hs - update 5, June 2020
As described in the version 1 and 2 of the FSN-CPS-2019-022, the lots 419260, 436777 of Elecsys Troponin T hs (08569873 190) and ...
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CARDIONOVUM GmbH, FSN-FO-40 no.11/2019, LEGFLOW OTW/RX Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
The purpose of this communication is now to draw your attention to updates that will be made to the IFUs for these devices ...
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Randox Laboratories Ltd, FSN-REC471, RANDOX LIPASE (LPS)
Randox have confirmed imprecision of quality control and patient samples when using Randox Lipase reagent batches listed in the ...
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Mikrogen GmbH, FSN-DE/202001, recomWell Helicobacter IgA
Our quality control and customer feedback management revealed, that the above mentioned batch contains cut-off control and ...
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Shenzhen Bioeasy Biotechnology Co Ltd, FSN-FSCA20200326001, BIOEASY™ 2019-Novel Coronavirus (2019-nCoV) Ag GIC
Low sensitivity was observed when comparing the device to PCR.
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Siemens Healthcare Diagnostics Inc, FSN-CC 20-06, ADVIA Centaur® XP Rubella G (Rub G) en ADVIA Centaur® XP Rubella M (Rub M)
The purpose of this communication is to inform you that Siemens Healthcare Diagnostics Inc. has confirmed customer complaints ...
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Beckman Coulter FA-000402 - DxA 5000
De gebruiksinstructies voor de DxA 5000 zijn mogelijk verwarrend omtrent het hergebruik van monster-ID's. Beckman Coulter heeft ...
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Siemens Healthcare Diagnostics Inc, FSN-ACHC 20-10, Chemistry Calibrator
The purpose of this communication is to inform you of an issue with the Chemistry Calibrator (Chem Cal) lots indicated and ...