Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. 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

3. 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

4. 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

5. Chromsystems FSC 1-2020 - Multilevel Plasma Calibrator Set Neuroleptics 1

   lnternal investigations demonstrate  that existing lot #2219 on the market of 3PLUS l Multilevel Plasma Calibrator Set ...

   Waarschuwing | 12-03-2020

6. Siemens ACHC 20-02 - Dimension Total Bilirubin (TBI) assay

   Siemens Healthcare Diagnostics has become aware that the United Kingdom Medicines and Healthcare products Regulatory Agency ...

   Waarschuwing | 26-02-2020

7. bioMérieux FSCA 4647 - VIDAS NT-proBNP2

   Following customers’ complaints about error analysis during calibration, bioMérieux investigation has confirmed an issue with the ...

   Waarschuwing | 24-02-2020

8. BioMerieux Inc FSCA 4654 - VITEK® 2 AST-N371 TEST KIT 20 CARDS

   A potential issue was identified relating to the top seal of card pouches for the VITEK® 2 test card lot AST-N371 0210932204. ...

   Waarschuwing | 19-02-2020

9. BioFire_bioMérieux FSCA 4593 - BioFire FilmArray® Blood Culture Identification (BCID) panel tests

   The purpose of this letter is to inform you that BioFire Diagnostics, LLC has identified an increased risk of false positive ...

   Waarschuwing | 06-02-2020

10. bioMérieux FSCA 4613 - NUCLISENS® Lysis Buffer

    Following a customer complaint about colored eluates, bioMérieux investigation has confirmed an issue with this specific lot ...

    Waarschuwing | 13-01-2020