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  1. Abbott Vascular, Clip Delivery System September 07 2022, MitraClip and TriClip Delivery Systems

    Het hogere aantal meldingen betreft clips waarbij het niet mogelijk is de ‘definitieve armhoek te bepalen’ (EFAA,Establish Final ...

    Waarschuwing | 03-10-2022

  2. Astraia software GmbH, 2022-02-02 CAPA AST-7150,astraia - software for women's health - obstretic and gynaecological database application

    We would like to inform you as the user/reseller of astraia about a possible bug in transferring measurement data, used for the ...

    Waarschuwing | 29-09-2022

  3. 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, ...

    Waarschuwing | 28-09-2022

  4. Sentec AG, CAPA 0599, NeoContactAgent Kit

    Met dit Marktveiligheidsbericht willen wij u informeren dat zichtbare verontreiniging werd ontdekt in ongeveer 0.1% van de ...

    Waarschuwing | 27-09-2022

  5. 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) ...

    Waarschuwing | 27-09-2022

  6. 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 ...

    Waarschuwing | 27-09-2022

  7. 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 ...

    Waarschuwing | 27-09-2022

  8. 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 ...

    Waarschuwing | 27-09-2022

  9. 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 ...

    Waarschuwing | 26-09-2022

  10. 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 ...

    Waarschuwing | 26-09-2022