Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
3.325 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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ShenZhen Cleanmo Technology, IT2045270, flocked swabs for nasal samples collection
The AR received the signal that the exported swabs are missing the four-digit number of the Notified Body.Through investigation, ...
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Sentec AG, CAPA 0599, NeoContactAgent Kit
Met dit Marktveiligheidsbericht willen wij u informeren dat zichtbare verontreiniging werd ontdekt in ongeveer 0.1% van de ...
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Abbott Hematology, FA09SEP2022, Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module
The Alinity h-series System Control Center (SCC) Application Software Version 4.3 (and below) and the Local User Interface (LUI) ...
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Actim Oy, 725, Actim 1ngeni
It is possible that in some rare cases when the IGFBP-1 concentration in the sample is near the cut-off of the test, the Actim ...
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Abbott, Clip Delivery System September 08, 2022, MitraClip- en TriClip- Delivery System(s)
Het hogere aantal meldingen betreft clips waarbij het niet mogelijk is de ‘definitieve armhoek te bepalen’ (EFAA, Establish Final ...
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DiaMed GmbH, FSN-FSCA 002-22, IH-QC8
Following two customer complaints, it has been confirmed that tubes from the impacted lot may present clots of red blood cells ...
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Siemens Healthcare Diagnostics Products GmbH, PP-22-003-A-C, N Antiserum to Human IgG
Siemens Healthcare Diagnostics Products GmbH has confirmed that the N Antiserum to Human IgG lots listed in Tables 1 and 2 are ...
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Illumina, QI-00949, VeriSeq™ NIPT Solution v2
In September 2020, you received a new VeriSeq NIPT Solution v2 system installation which should have included WFM v2.4 on a ...
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FARAPULSE, 92912936-FA, FARAWAVE - FARASTAR - FARAPULSE SYSTEM
Het FARAPULSE PFA-systeem is ontworpen/beoogd voor gebruik voor de isolatie van longaderen tijdens de ablatie van paroxismaal ...
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W. L. Gore & Associates, Inc. Medical Products Division, 2017233.09.15.2022.001-R, GORE® CARDIOFORM ASD Occluder
Gore has identified one batch of GORE® CARDIOFORM ASD Occluder devices that was incorrectly released following a documented ...