Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Leica Biosystems - ASP6025 Tissue Processor

   The current incorrect labels specify 125Va.c. as maximum voltage. It has been identified, that if somebody connects such 125Va.c. ...

   Waarschuwing | 30-06-2017

2. SEBIA VIG-06-20 17-01 - MINICAP IMMUNOTYPING, CAPILLARYS IMMUNOTYPING, CAPI 3 IMMUNOTYPING

   SEBIA performs a constant follow-up of the quality of its products, its processes and analyzes all customer observations, and our ...

   Waarschuwing | 28-06-2017

3. 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

4. Siemens Healthcare Diagnostics Inc CC 17-12 - ADVIA Centaur BR 1and 5 Ready Pack Primary Reagent

   Siemens Healthcare Diagnostics has confirmed that the ADVIA Centaur BR (CA 27.29) assay does not dilute linearly when used with ...

   Waarschuwing | 27-06-2017

5. Field Safety Notice: QIAGEN - QIAamp DSP Virus-kit

   Uit onderzoek is gebleken dat het probleem is veroorzaakt door een afwijking van de juiste bewaarcondities. Dit heeft geleid tot ...

   Waarschuwing | 22-06-2017

6. Field Safety Notice: Roche - cobas e 411 and Elecsys 2010 analyzer

   We regret to inform you that in very rare cases a software (SW) malfunction in the Sample&Control datafile can occur which may ...

   Waarschuwing | 21-06-2017

7. Field Safety Notice: ThermoFisher - B·R·A·H·M·S anti-Tgn RIA

   Starting with B·R·A·H·M·S anti-Tgn RIA lot 119854 we informed you about a shift in the reference range depending on the storage ...

   Waarschuwing | 14-06-2017

8. 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

9. Field Safety Notice: Siemens Healthcare Diagnostics Products, Dimension Vista® CER Flex® Reagent

   Siemens Healthineers has confirmed a negative bias of approximately -20% for results obtained with Dimension Vista® CER Flex® ...

   Waarschuwing | 09-06-2017

10. Field Safety Notice: Siemens Healthcare Diagnostics, ADVIA Centaur® -XP® -XPT®

    Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ...

    Waarschuwing | 09-06-2017