Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Thermo Fisher PO5133A.2635614 - Oxoid Bacillus Cereus Medium (MYP)

   An investigation has confirmed that Bacillus Cereus Medium (MYP), PO5133A, lot 2635614 has been incorrectly labelled. The outer ...

   Waarschuwing | 11-04-2019

2. Randox Laboratories, REC341, Randox Liquid Cardiac Control

   Randox has confirmed a change in recovery with regards to NTproBNP in the Liquid Cardiac Control lots detailed in the table ...

   Waarschuwing | 07-03-2019

3. Stago, RC-18-0003, STA® - VWF:RCo

   The root cause investigations have found a disturbance of these measures at the standard dilution of the plasma only (1:4 ...

   Waarschuwing | 28-01-2019

4. Thermo Fisher Scientific PB1229A.2561395 - ThermoScientific Oxoid Mueller Hinton + Horse Blood + NAD (4mm)

   A technical investigation has confirmed that Thermo Scientific™ Mueller Hinton + Horse Blood + NAD (4mm), PB1229A Lot 2561395 ...

   Waarschuwing | 22-01-2019

5. Diagnostica Stago RC-17-0019 - (STA) Neoplastine CI (Plus)

   Following a customer complaint, Stago has investigated and confirmed a defect of homogeneity within lot, for lots listed in the ...

   Waarschuwing | 17-10-2017

6. Thermo Scientific FSN-R30165101-04-10-2017 - Remel Vibrio Cholerae Inaba agglutinating serum

   An internal technical investigation has determined that Thermo Scientific™ RemelTM Vibrio cholerae inaba Agglutinating Serum ...

   Waarschuwing | 04-10-2017

7. Thermo Fisher Scientific Microbiology, ThermoScientific Oxoid CAZ10 CEFTAZIDIME, CT1629B

   An internal technical investigation has confirmed that the concentration of antibiotic in ThermoScientific Oxoid CAZ10 ...

   Waarschuwing | 12-09-2017

8. Randox REC305 - Liquid Cardiac Control - Level 3

   Randox Laboratories has confirmed Troponin T and Troponin I levels in lot 4069CK have deteriorated. This may result in recovery ...

   Waarschuwing | 01-08-2017

9. Siemens CC 17-18 - Advia Centaur XPT System T3

   Siemens has identified an issue when scanning the 2D barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit ...

   Waarschuwing | 31-07-2017

10. Field Safety Notice: Beckman Coulter - DxH 500 REF B40601, SW 1.0.2

    As a result of internal investigations, BEC has become aware that when the instrument temperature is exceeded, the DxH 500 allows ...

    Waarschuwing | 02-06-2017