Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Immucor, Capture-R®Ready-ID®

   Further DNA testing of donor D1741 has confirmed the donor as V–, instead of V+ as indicated on the Master List. Fabrikant: ...

   Waarschuwing | 20-02-2017

2. Field Safety Notice: Randox Laboratories - Liquid Cardiac Control

   Randox has confirmed a change in recovery with regard to Myoglobin in the lots of the Liquid Cardiac Control listed above for the ...

   Waarschuwing | 17-02-2017

3. Field Safety Notice: Euro Diagnostica - Diastat Ana Elisa kit

   The reason for this field safety notice is that the affected kit lot TS 2076 of DIASTAT ANA ELISA is at risk of malfunctioning ...

   Waarschuwing | 15-02-2017

4. Abbott Laboratories FA13FEB2017 - CELL-DYN Ruby

   Abbott Hematology has become aware that the CELL‐DYN Ruby instrument at your facility has a printed circuit board assembly (PCBA) ...

   Waarschuwing | 13-02-2017

5. Field Safety Notice: DiaMed GmbH, ID-DiaCell's

   We would like to share with you, and your team, information about unexpected reactions primarily on eluates and QC samples but ...

   Waarschuwing | 10-02-2017

6. Field Safety Notice: Iris International (IRIS), iChemVELOCITY

   Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility ...

   Waarschuwing | 08-02-2017

7. Field Safety Notice: Siemens Healthcare, ADVIA® Centaur XPT

   Siemens Healthcare Diagnostics has identified the issues described in Table 2 for all the ADVIA® Centaur XPT system software ...

   Waarschuwing | 08-02-2017

8. Field Safety Notice: Phadia_Thermo Fisher - EliA and ImmunoCAP Specific IgA/IgG Sample Diluent

   There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles in the below mentioned products and ...

   Waarschuwing | 07-02-2017

9. Field Safety Notice: Roche - Elecsys TSH and PTH assay

   We regret to inform you that in case the Elecsys PTH (1-84) assay lot 185522 (expiry date May 2016) and Elecsys TSH assay lot ...

   Waarschuwing | 03-02-2017

10. Orion Diagnostica - QuikRead FOB Sampling Set, QuikRead FOB quantitative and QuikRead go iFOBT

    Orion Diagnostica has during its regular stability tests noticed that QuikRead FOB Sampling Set (Cat.No. 138822) vials do not ...

    Waarschuwing | 07-12-2016