Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Sebia - MINICAP PROTEIN(E) 6

   Gebruikers hebben aan het licht gebracht dat het bufferlot in enkele kits niet het verwachte lot is: lot 12126/01 in plaats van ...

   Waarschuwing | 24-08-2017

2. Field Safety Notice: Becton Dickinson, BD MAX Vaginal Panel -UVE Specimen Collection Kit

   The following information is intended to provide clinicians and patients with precautions in relation to current Instructions For ...

   Waarschuwing | 19-07-2017

3. Field Safety Notice: Alere - Alere HIV Combo

   Onze interne onderzoeken hebben aangetoond dat, wanneer EDTA-volbloedmonsters worden getest, de bovenstaande lotnummers vaker een ...

   Waarschuwing | 14-07-2017

4. 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

5. 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

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. 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

9. 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

10. Field Safety Notice: bioMerieux, VITEK® 2 - Colistin (cs01n) Performance

    A performance issue has been identified with colistin (cs01n) Fabrikant: bioMerieux Product: VITEK® 2 - Colistin (cs01n) ...

    Waarschuwing | 22-05-2017