Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Radiometer Medical ApS FAN 915-411 ABL80 FLEX CO-OX

   Radiometer has become aware that the internal barcode reader, included in all versions of the ABL80 analyzer, may potentially ...

   Waarschuwing | 23-04-2020

2. Life Technologies Corporation, a part of Thermo Fisher Scientific PR423912 Gibco® Gurr Buffer Tablets

   We have become aware through customer complaints that two (2) lots of Gibco® Gurr Buffer Tablets (Catalog #: 10582-013, lot ...

   Waarschuwing | 21-04-2020

3. Roche Diagnostics GmbH CN-506036 (SBN-CPS-2020-003) cobas® 6500 urine analyzer series

   A mismatch of results of cobas u 601 urine analyzer and cobas u 701 microscopy analyzer for the same sample was observed after a ...

   Waarschuwing | 16-04-2020

4. Fast-Track Diagnostics S.a.r.l. FA-2020-02 FTD Vesicular rash

   Het doel van deze communicatie is u te informeren over prestatieproblemen in verband met de ontoereikendheid van validatie en ...

   Waarschuwing | 10-04-2020

5. The Binding Site Group Ltd. AE050 - Optilite Analyser

   Volgens de Binding site is de kans dat dit probleem zich voordoet zeer klein en een klinisch risico lijkt onwaarschijnlijk. De ...

   Waarschuwing | 09-04-2020

6. Siemens PH-20-009 - Coagulation Factor V Deficient Plasma

   Siemens Healthcare Diagnostics Products GmbH has confirmed that some packages of Coagulation Factor V Deficient Plasma lot 504974 ...

   Waarschuwing | 08-04-2020

7. Radiometer Medical ApS FAN 915-409 AQT90 FLEX analyzers

   Radiometer has become aware that the barcode readers in the bottom edge of the display and behind the inlet wheel may ...

   Waarschuwing | 08-04-2020

8. bioMerieux Inc, FSN-FSCA 4712, VITEK®2 AST-P652 TEST KITS 20 CARDS

   Deze kennisgeving heeft betrekking op potentiële valse positieve resultaten in het Cefoxitin Screen (OXSF) voor Staphylococcus ...

   Waarschuwing | 23-03-2020

9. Abbott Diagnostics CAPA-2386 - Power supply provided with Afinion™2 and Alere Afinion™ AS100 Analyzer

   Abbott has received complaints for the Afinion Analyzer systems related to electrostatic discharge and sparking of the power ...

   Waarschuwing | 23-03-2020

10. Inpeco S.A. FSCA - AP2 - 202003 - 03 Aptio Automation

    The Centrifuge Module tube loading algorithm included in the firmware versions mentioned above is not in compliance with the ...

    Waarschuwing | 23-03-2020