Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Roche Diagnostics, cobas® MPX Test, CE-IVD, cobas® DPX Test, CE-IVD

   Under specific conditions, there is a possibility that Target specific results sent to a customer’s LIS may not match those ...

   Waarschuwing | 10-05-2017

2. Field Safety Notice: ALBA Bioscience, Quotient, ALBAclone® Advanced Partial RhD Typing Kit

   Performance data for component L (Anti-D LHM57/17) of the lot listed above has indicated deterioration in potency. Fabrikant: ...

   Waarschuwing | 05-05-2017

3. Field Safety Notice: Beckman Coulter, UniCel DxH 800 en 600 Coulter Cellular Analysis System

   There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood ...

   Waarschuwing | 03-05-2017

4. 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

5. 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

6. Field Safety Notice: Siemens Healthcare, ADVIA Centaur Systems Insulin Assay

   Siemens Healthcare Diagnostics is providing this Urgent Field Safety Notice to communicate the restoration of the ADVIA Centaur ...

   Waarschuwing | 26-04-2017

7. 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

8. Field Safety Notice: BÜHLMANN Laboratories AG, CALEX® Cap

   This Field Safety notice provides additional technical information about the expected calprotectin result agreement between stool ...

   Waarschuwing | 21-04-2017

9. Field Safety Notice: bioMérieux, VITEK® 2 Identification / Antimicrobial Susceptibility Test Cards referenced in Appendix A

   A potential issue was identified related to the white pouch which contains VITEK® 2 test cards for the product lots specified in ...

   Waarschuwing | 20-04-2017

10. Field Safety Notice: Siemens - Dimension EXL _Vista

    Interfering Substances section of the current Dimension and Dimension Vista Instructions For Use for Dimension TNI, Dimension ...

    Waarschuwing | 20-04-2017