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  1. Mevion Medical Systems FSCA_220126 - Mevion S250i

    Mevion was informed of an instance where a user changed only the Setup isocenter in ARIA in a previously approved plan, without ...

    Waarschuwing | 24-02-2022

  2. SEBIA, FSN-FSCA-02-2022-01, CAPI 3 IMMUNOTYPING

    We inform you that a user of these kits highlighted an inversion between the anti-Ig M and anti-Lambda antisera. Our ...

    Waarschuwing | 24-02-2022

  3. Abbott Molecular, Inc., FSN-FA-AM-FEB2022-267, Integrated Reaction Unit (IRU)

    Abbott has received complaints associated with the Alinity m Reaction Vessels (RVs) detaching from the RV Cap during transport by ...

    Waarschuwing | 24-02-2022

  4. BioMérieux SA, FSN-FSCA 5537, VIDAS® CMV IgM

    BioMérieux received complaints about calibration issue observed on VIDAS® CMV IgM (ref 30205, 30205-01), Lot 1008873250 and Lot ...

    Waarschuwing | 24-02-2022

  5. Mikrogen GmbH, FSN-DE/202001, ampliCube HEV 2.0 quant

    With this letter we would like to inform you about a mistake in the instructions for use of our ampliCube HEV 2.0 Quant (Art. no. ...

    Waarschuwing | 24-02-2022

  6. Siemens Healthcare Diagnostics Inc, FSN-ACHC 22-02, Lithium_2 (LITH_2) reagents, Enzymatic Hemoglobin A1c (A1c_E) reagents, Calcium_2 (CA_2) reagents, Fructosamine (Fruc) reagents

    Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient ...

    Waarschuwing | 24-02-2022

  7. Siemens Healthcare Diagnostics Inc, FSN-VC 22-01, Dimension Vista Magnesium Flex reagent cartridge

    Siemens Healthineers has confirmed that the Dimension Vista Magnesium (MG) Flex reagent cartridge lots listed in Table 1 may show ...

    Waarschuwing | 24-02-2022

  8. Sysmex FSN524700045 - FLUOROCELL PLT

    Unfortunately it has come to our attention that Sysmex haematology IVD reagent Fluorocell PLT might show a decrease of the side ...

    Waarschuwing | 23-02-2022

  9. Hologic FA-00197 - PANTHER FUSION EXTRACTION REAGENT-X kit

    When the Panther Fusion Capture Reagent-X has been stored at 28oC or higher and is used to expiration, there is a possibility for ...

    Waarschuwing | 23-02-2022

  10. Abbott FA03FEB2022 - Alinity s System

    Abbott has identified an error associated with the reagent probe (R1) wash cycle introduced in the Alinity s System software (SW) ...

    Waarschuwing | 23-02-2022

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