Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Inpeco SA FSCA-AP2-202008-03 - Aptio Automation

   The firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) has the potential to mis-associate sample IDs leading to ...

   Waarschuwing | 07-08-2020

2. Beckman Coulter, 23038, DxI 9000 Access Immunoassay Analyzer

   Beckman Coulter heeft vastgesteld dat de DxI 9000 Access- immunoassay-analyser monsters mogelijk onjuist identificeert.

   Waarschuwing | 20-09-2023

3. CareDx AB, FSN-A-2021-091, Olerup QTYPE 11

   Urgent Field Safety Notice Olerup QTYPE 11 E047.

   Waarschuwing | 11-06-2021

4. SENTINEL CH. S.p.A., FSN-01/2021, ACE Control Set

   This letter contains important information regarding the ACE Control Set product REF 1667001.

   Waarschuwing | 30-04-2021

5. Actim Oy, FSN-240002483, Actim CRP

   Actim Oy has observed that in occasional Actim CRP dipsticks, the third test line (>80 mg/L) is lighter than specified.

   Waarschuwing | 02-12-2020

6. Actim Oy, FSN-240002483, Actim CRP (31031ETAC)

   The purpose of this letter is to inform you of a recall for product correction for the Actim CRP (31031ETAC).

   Waarschuwing | 01-10-2020

7. Biocartis BC-013089 - Idylla™ EGFR Mutation Test

   The Idylla™ EGFR Mutation Test Instructions for Use (IFU) has been updated based on customer feedback and a request received from ...

   Waarschuwing | 20-02-2020

8. Randox Laboratories Ltd REC270 - Evidence Investigator

   In response to operator feedback and in line with our policy of continuous improvement, the Evidence Investigator analyser ...

   Waarschuwing | 02-03-2017

9. QIAGEN GmbH, DEV-00000, EZ2 Connect MDx

   Er is een probleem geïdentificeerd met het EZ2 Connect MDx-instrument. Dit probleem wordt veroorzaakt door onvoldoende ...

   Waarschuwing | 18-03-2024

10. SENTINEL CH. S.p.A, FSN-07/2020, Zine

    This letter contains important information regarding the ZINC product REF 17640H lot 90227.

    Waarschuwing | 30-10-2020