Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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Hitachi High Technologies Corporation (HHT), FSN-CN-509982,CN-530429 (SBN-CPS- 2020-013), cobas 8000 Core Unit,cobas pro sample supply unit,cobas c 513 analyzer commercial system
Roche has received one customer complaint for the cobas 8000 modular analyzer series where due to a software limitation the ...
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DiaSorin Ine. US, FSN-WS1000069, LIAISON® 1-84 PTH Assay
DiaSorin has confirmed that the LIAISON® 1-84 PTH Assay {REF 310630) lot numbers 134909, 134909A and 1349098, may produce falsely ...
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Siemens Healthcare Diagnostics Inc., FSN-ACHC 21-01, Triglyceride IVD, kit, enzyme spectrophotometry
Siemens Healthcare Diagnostics Inc. has become aware that falsely depressed results may be observed in the presence of ...
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IQ Products BV, FSN-FSCA-2020-01- INC323, FMH QuikQuant
IQ Products BV meldt Filed Safety over FMH QuikQuant.
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Roche Molecular Systems, FSN-CN-516475, cobas z 480 analyzer
Roche received complaint cases alleging false positive or invalid results with select cobas® 4800 IVD assays.
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Siemens Healthcare Diagnostics Inc., FSN-ASW21-01, Atellica IM 1300 Analyzer and Atellica IM 1600
Siemens Healthcare Diagnostics has identified an issue with the Atellica Solution products through investigation of customer ...
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Abbott GmbH, FSN-FA12NOV2020, ARCHITECT Active-B12 (Holotranscobalamin) Reagent, Calibrators, Controls; Alinity i Active-B12 (Holotranscobalamin) Reagent, Calibrators, Controls
The purpose of this letter is to inform you of a product recall for the reformulated Alinity i/ARCHITECT Active‐B12 product.
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Chromsystems Instruments & Chemicals GmbH, FSN-2-2020, 6PLUS1 Multilevel Saliva Calibrator Set
Chromsystems Instruments & Chemicals GmbH meldt Field Safety over 6PLUS1 Multilevel Saliva Calibrator Set.
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bioMérieux SA, FSN-FSCA 4924, VIDAS® FT4
URGENT FIELD SAFETY NOTICE VIDAS® FT4
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SENTINEL CH. S.p.A, FSN-07/2020, Zine
This letter contains important information regarding the ZINC product REF 17640H lot 90227.