Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Hamamatsu Photonics K.K. Systems Division, 76-C0732, NanoZoomer Serie

   Under certain conditions it can happen that a digital slide is assigned an incorrect barcode as meta data. This can lead to a ...

   Waarschuwing | 19-04-2023

2. Field Safety Notice: Magellan Diagnostics Inc., LeadCare

   In navolging van de veiligheidsmededeling van de Amerikaanse Food and Drug Administration (FDA), strekt deze mededeling ten doel ...

   Waarschuwing | 19-07-2017

3. QuidelOrtho (Ortho Clinical Diagnostics Inc), CL2023-257, ORTHO VISION and VISION Max Analyzers for BioVue

   The wash protocol for ORTHO Sera Anti-Jkb on the ORTHO VISION / VISION Max BioVue Analyzer does not sufficiently clean the ...

   Waarschuwing | 23-11-2023

4. 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

5. 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

6. Siemens Healthcare Diagnostics Inc., CHC 23-01, ADVIA Chemistry Urinary.Cerebrospinal Fluid Protein

   Falsely depressed ECRE_2 results may be observed when the assay is processed after the UCFP test on ADVIA Chemistry systems.

   Waarschuwing | 14-08-2023

7. QIAGEN GmbH, FSN-CI 3028397, QIAstat-Dx® Respiratory SARS-CoV-2 Panel

   Deze dringende veiligheidsmededeling dient om u erover te informeren dat QIAGEN heeft vastgesteld dat bepaalde partijen van de ...

   Waarschuwing | 08-06-2023

8. Phadia AB, QA2023-05, EliA GBM Well

   Several customer complaints have been reported where specific samples produced false positive EliA GBM results. An investigation ...

   Waarschuwing | 31-05-2023

9. Illumina Inc, QI-01093, NextSeq 550Dx Instrument . MiSeq Dx Instrument

   Illumina neemt contact met u op vanwege een cybersecurityprobleem in de software van de Universal Copy Service (UCS) dat is ...

   Waarschuwing | 28-04-2023

10. Helena Biosciences Europe, FSN-NC643, ProtoFluor-Z Reagent Kit

    Mislabeled bottles of the PFZ reagent kit, which prevents calibration of the PFZ instrument. The calibrators of this lot will not ...

    Waarschuwing | 09-03-2023