Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Sentinel - MULTIGENT Creatinine (Enzymatic) assay

   Sentinel has detected a performance issue with the reagent 1 component of the three impacted lots listed above. This issue may ...

   Waarschuwing | 22-05-2017

2. Field Safety Notice: Abbott Diagnostics, ARCHITECT Free T4

   This Product Correction letter is being issued to provide you with information regarding a change of measuring interval for the ...

   Waarschuwing | 28-04-2017

3. Field Safety Notice: Hitachi, OUTPUT UNIT

   One complaint was received referring to 5 position racks at the Output Unit were not being smoothly pushed out into the tray, ...

   Waarschuwing | 27-04-2017

4. Field Safety Notice: Randox Laboratories, Liquid Cardiac Control

   Randox has confirmed a change in recovery with regards to CKMB in lot 3912CK of the Liquid Cardiac Control. Fabrikant: Randox ...

   Waarschuwing | 25-04-2017

5. Field Safety Notice: Abbott, ARCHITECT SHBG Reagents

   Abbott has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative ...

   Waarschuwing | 18-04-2017

6. Field Safety Notice: Beckman Coulter - AQUIOS CL Flow Cytometer

   Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly ...

   Waarschuwing | 13-04-2017

7. Field Safety Notice: Siemens Healthcare, ADVIA® Chemistry Systems

   Siemens Healthcare Diagnostics is providing an update to all ADVIA Chemistry Systems Lactate Dehydrogenase L-P (LDLP) and Lactate ...

   Waarschuwing | 22-02-2017

8. 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

9. 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

10. 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