Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Healthcare Diagnostics Inc. CSW 18-01 - ADVIA Centaur CP, XP, and XPT Systems

   Under certain scenarios, the system may allow dilutions to be processed for up to 28 days. Internal investigation has observed a ...

   Waarschuwing | 29-12-2017

2. Miltenyi Biotec - CD34/CD133 Enumeration Kit, human (IVD)

   We would like to inform you that the formulas for the calculation of cell concentrations as indicated in the package Insert for ...

   Waarschuwing | 27-11-2017

3. Roche Diagnostics FSN SBN-RMD-2017-009 - cobas® MRSA/SA Nucleic acid test

   Roche Diagnostics is advising that you discontinue the use of and discard any remaining inventory of the cobas® MRSA/SA Nucleic ...

   Waarschuwing | 27-10-2017

4. Sanquin Reagents FSN 103549 - Screening panel

   Bij kwaliteitsonderzoek is gebleken dat cel van deze panels (donorcode 384549) op het bijbehorende antigram ten onrechte staat ...

   Waarschuwing | 26-10-2017

5. Agilent Technologies CAPA00718 VN102 - Monoclonal Mouse Anti-Human CDX2, Clone Dak-CDX2

   Het Analysecertificaat (CoA) en de primaire labels van de getroffen ampullen M3636 zijn foutief gelabeld met een onjuiste waarde ...

   Waarschuwing | 25-10-2017

6. Siemens PI-17-007 - Enzygnost

   Siemens Healthcare Diagnostics has confirmed that the above listed lots of Enzygnost® HBsAg 6.0 show an increased number of ...

   Waarschuwing | 23-10-2017

7. Cepheid 17FAR008 - Xpert® MRSA

   Cepheid heeft meldingen ontvangen dat een aantal van onze klanten een groter aantal ongeldige resultaten heeft verkregen dan in ...

   Waarschuwing | 20-10-2017

8. Thermo Fisher Scientific FSN CM0405B - ThermoScientific™ Oxoid™Mueller Hinton Broth

   An internal technical investigation by Oxoid Limited, part of Thermo Fisher Scientific, has confirmed that ThermoScientific™ ...

   Waarschuwing | 19-10-2017

9. 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

10. bioMérieux FSCA3666 - VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit

    Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for ...

    Waarschuwing | 16-10-2017