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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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 ...

    Waarschuwing | 26-09-2022