Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Roche - cobas c 501 and c 502 module

   We regret to inform you that an operator was injured during a maintenance task, when removing the Ultrasonic Mixer Cover (USM ...

   Waarschuwing | 11-07-2017

2. Field Safety Notice: Beckman Coulter - COULTER LH750_LH780_LH500_HmX CP_HmX AL Analyzers

   Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the ...

   Waarschuwing | 28-06-2017

3. Nova Biomedical, Stat Profile Prime

   Nova Biomedical Corporation has recently become aware of a software issue on the Stat Profile Prime Analyzers listed above when ...

   Waarschuwing | 09-06-2017

4. Field Safety Notice: Beckman Coulter - Synchron Systems AQUA Cal 1

   Beckman Coulter has confirmed a negative shift of 5 mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with ...

   Waarschuwing | 31-05-2017

5. Field Safety Notice: Beckman Coulter, Access Total T3, Access Thyroglobulin, Access Free T4

   Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed ...

   Waarschuwing | 17-05-2017

6. 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

7. 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

8. 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

9. Field Safety Notice: Helena - Cascade Abrazo c-ACT-LR cards

   Some cards in this lot have shown occasional shorter or longer clot times than expected variation, as evidenced investigation by ...

   Waarschuwing | 05-04-2017

10. Field Safety Notice: Beckman Coulter, Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents

    Beckman Coulter has identified the following drugs as potential sources of interference... Fabrikant: Beckman Coulter Product: ...

    Waarschuwing | 03-04-2017