Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. lmmunotech S.A.S. - A Beckman Coulter Company, 23043, Access hsTnI Reagent

   Beckman Coulter heeft vastgesteld dat er na de upgrade naar systeemsoftware 7.0.0 en hoger een restrisico op intratestoverdracht ...

   Waarschuwing | 05-10-2023

2. Siemens Healthcare Diagnostics Inc., AIMC 23-08, Atellica IM Free Beta Human Chorionic Gonadotropin (FBHCG) ADVIA Centaur Free Beta Human Chorionic Gonadotropin (FBHCG)

   The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...

   Waarschuwing | 28-09-2023

3. Becton, Dickinson and Company, IDS-23-4859, BD BACTEC™ Plus Aerobic/F Culture Vials

   BD heeft via twee klachten van klanten bevestigd dat bepaalde flesjes van de hierboven vermelde BD BACTEC™ Plus ...

   Waarschuwing | 21-09-2023

4. 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

5. Randox Laboratories Ltd., Liquid Assayed Chemistry Control Premium Plus Leve

   Randox Laboratories can confirm that there has been a transcription error in the lnstructions for Use (IFU) for the Liquid ...

   Waarschuwing | 15-09-2023

6. Techno-path Manufacturing Ltd., FSN-RE23001, Multichem Alinity product range

   Technopath Manufacturing Ltd. bas identified an issue with the glass vial commodity used to fill the products as listed above. ...

   Waarschuwing | 12-09-2023

7. Alba Bioscience Limited (Ltd.), 00003-2023, ALBAcyte® Reagent Red Cells A1

   Investigations have identified that the product is mis-labeled in that one of the three units used to manufacture this reagent ...

   Waarschuwing | 31-08-2023

8. Alba Bioscience Limited (Ltd.), 00002-2023, ORTHO™ Sera Anti - Lea

   Een onderzoek naar aanleiding van klachten van klanten heeft bevestigd dat de genoemde partijen ORTHOTM Sera Anti-Lea onverwachte ...

   Waarschuwing | 29-08-2023

9. Diagnostic Grifols S.A., 800012097, ERYTRA EFLEXIS

   The analyzer may give incorrect interpretations of a profile that includes multiple techniques under certain conditions.

   Waarschuwing | 28-08-2023

10. Siemens Healthcare Diagnostics Inc., CHC 23-02, ADVIA Chemistry Iron_2 (IRON_2) Reagents

    Siemens Healthcare Diagnostics Inc. has confirmed, through investigation of customer complaints, the potential for a positive ...

    Waarschuwing | 28-08-2023