Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. bioMérieux, FCA 4532, BACT_ALERT VIRTUO

   Baxter Healthcare Corporation is issuing a voluntary product recall for the ArtiSet Blood Tubing Sets listed below due to the ...

   Waarschuwing | 30-10-2019

2. bioMérieux SA, FSCA 4553, Cetrimide Agar

   Based on the investigation results, there is a potential risk for False negative results for Pseudomonas aeruginosa with lot. # ...

   Waarschuwing | 29-10-2019

3. IT2027888, BioMerieux Inc, FSCA 4538, VIDAS 3

   Following Customers complaints, investigations have been initiated on potentially false results obtained on VIDAS 3 with an ...

   Waarschuwing | 29-10-2019

4. Abbott, FA23OCT2019, Alinity c Carbon Dioxide Reagent Kit

   This letter is to inform you that Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed ...

   Waarschuwing | 23-10-2019

5. Philips Electronics, FSN 0113954713, LABOSYS

   Philips heeft een fout geconstateerd bij het opvragen van een BSN bij de SBV-Z in LABOSYS, waardoor een verkeerd BSN gekoppeld ...

   Waarschuwing | 15-10-2019

6. Thermo Fisher Scientific, MA0120DF.2423244, ThermoScientificTM OxoidTM Ceftazidime256 M.I.C.E.

   An internal technical investigation by Oxoid Limited, part of Thermo Fisher Scientific, has confirmed that Ceftazidime 256 ...

   Waarschuwing | 15-10-2019

7. Beckman Coulter, FA-000135, UniCel DxH Slidemaker Stainer

   In zeldzame gevallen kan de dispense probe worden gebogen als de Sample Aspiration Module(SAM) zich niet in de veilige positie ...

   Waarschuwing | 14-10-2019

8. Ortho Clinical Diagnostics, CL2019-254, ORTHO VISION and VISION Max Analyzers

   As part of a Field Safety Corrective Action, this notification is to inform you of an ORTHO VISION and ORTHO VISION Max Analyzer ...

   Waarschuwing | 07-10-2019

9. Randox Laboratories, REC414, Liquid Cardiac Controls

   Randox has observed a decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots of Liquid ...

   Waarschuwing | 01-10-2019

10. Roche Diagnostics, CN-417625 (SB-CPS-2019-018), Cardiac Pipettes

    The following issues were observed: 8 cases where the needle came off the pipette and 1 case where the needle became stuck in a ...

    Waarschuwing | 01-10-2019