Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Healthcare Diagnostics Inc., POC 23-018, RAPIDPOINT 500 Blood Gas System and RAPIDPOINT 500e Blood Gas System

   Siemens Healthcare Diagnostics Inc. has determined that two drugs, Perhexiline Maleate and Atomoxetine Hydrochloride, may ...

   Waarschuwing | 27-10-2023

2. Randox Laboratories Ltd., REC692, Randox G6PDH

   Randox Laboratories voert een terugroepactie uit voor G-6-PDH-reagens, catalogusnummer PD410, batch 629055. Het R2 NADP- en ...

   Waarschuwing | 12-10-2023

3. Waters Corporation, 1218959-09/27/2023-001-C, Waters Xevo TQ-S Micro IVD

   After investigation, a design vulnerability relating to firmware of Xevo TQ-S Micro IVD has been identified that, under specific ...

   Waarschuwing | 12-10-2023

4. SENTINEL CH. S.p.A., 03/2023; FA02OCT2023, IRON, IRON, Alinity c Iron Reagent

   It has been identified that when using the ARCHITECT and Alinity c Iron products for the lots listed above, variable results can ...

   Waarschuwing | 12-10-2023

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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