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  1. Abbott FA24MAR2016 - CELL-DYN Emerald Cleaner

    Abbott has identified occurrences where the CELL-DYN Emerald analyzer generates Quality Control (QC) Out Of Range Low for ...

    Waarschuwing | 24-03-2016

  2. AB Germa FSCA_ENG 160317 - vacuum pump foot pump

    We have identified a quality deviation in the latest production lot of Footrest Vacuum Pumps. During Germa quality check before ...

    Waarschuwing | 16-03-2016

  3. Leica FSCA-2016-01 - 3200MD series and 4500MD series

    An issue has been identified with Analyst MD software where under certain conditions a user can be presented with incorrect ...

    Waarschuwing | 04-03-2016

  4. Siemens CC 16-07 - ACS 180,ADVIA Centaur Calibrator E

    Siemens Healthcare Diagnostics has confirmed a lot to lot bias with Calibrator E for the ADVIA Centaur Testosterone assay.

    Waarschuwing | 15-02-2016

  5. Radiometer Medical ApS FAN 915-347 - Troponin T (8-test) Test Kit, bnp, d-dimer, TnI

    RADIOMETER has recently become aware of a potential risk of receiving false negative results with the AQT90 FLEX Test Kit Boxes ...

    Waarschuwing | 08-02-2016

  6. Sekisui Diagnostics ACET-506-2016-01-22 - Sekure Acetaminophen L3K Assay

    Sekisui has investigated complaints related to the formation of crystals in the R2 reagent  and/or  shift of  controls when left ...

    Waarschuwing | 22-01-2016

  7. bioMérieux FSCA 2752 - API® ZYM Bx2

    Based on discrepant results (False negative results) reported from the field, bioMérieux initiated a complaint investigation to ...

    Waarschuwing | 15-01-2016

  8. Siemens Healthcare Diagnostics Products GmbH PH-16-003 - BCS System, BCS XP Analyzer System, OVIO032, OVOB032

    Siemens Healthcare Diagnostics has observed that in very rare cases false short clotting times for PT on BCS and BCS XP with Dade ...

    Waarschuwing | 23-12-2015

  9. Medis Medical Image Systems B.V.16M0003 - QIvus 2.0, 2.1, 2.2. en 3.0

    "The IMap™, V , TVC Chemogram™ and OCT  modules of Qlvus are lntended for research use only and are not to  be used for clinical  ...

    Waarschuwing | 22-12-2015

  10. Becton Dickinson BDB-15-657 - FMC7 FITC

    The functional degradation has the effect of reducing the percent positive from 100% down to approximately 87%. The adverse ...

    Waarschuwing | 17-12-2015