Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Siemens Healthcare Diagnostics Inc, FSN-ACHC 22-07, Atellica CH Lithium_2 (LITH_2); Atellica CH Lithium (Li)

   Siemens Healthcare Diagnostics Inc. has confirmed customer complaints indicating the potential for falsely elevated LITH_2 and Li ...

   Waarschuwing | 11-10-2022

2. ZOLL Circulation, FSN-FSCA-2022-09-001, AutoPulse Platform (AP) Li-Ion Batteries

   Sinds mei 2022 heeft het Post Market Surveillance Team (team voor toezicht na introductie op de markt) van ZOLL Circulation een ...

   Waarschuwing | 11-10-2022

3. Abbott Hematology, FA09SEP2022, Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module

   The Alinity h-series System Control Center (SCC) Application Software Version 4.3 (and below) and the Local User Interface (LUI) ...

   Waarschuwing | 27-09-2022

4. Actim Oy, 725, Actim 1ngeni

   It is possible that in some rare cases when the IGFBP-1 concentration in the sample is near the cut-off of the test, the Actim ...

   Waarschuwing | 27-09-2022

5. DiaMed GmbH, FSN-FSCA 002-22, IH-QC8

   Following two customer complaints, it has been confirmed that tubes from the impacted lot may present clots of red blood cells ...

   Waarschuwing | 27-09-2022

6. Siemens Healthcare Diagnostics Products GmbH, PP-22-003-A-C, N Antiserum to Human IgG

   Siemens Healthcare Diagnostics Products GmbH has confirmed that the N Antiserum to Human IgG lots listed in Tables 1 and 2 are ...

   Waarschuwing | 26-09-2022

7. Illumina, QI-00949, VeriSeq™ NIPT Solution v2

   In September 2020, you received a new VeriSeq NIPT Solution v2 system installation which should have included WFM v2.4 on a ...

   Waarschuwing | 26-09-2022

8. Biomedical Data Solutions, 73555, Ortho Connect

   When Cancelling an Edit during Result Review, Approved results are incorrectly saved using the cancelled data.  

   Waarschuwing | 07-09-2022

9. Becton Dickinson GmbH, FSN-IDS-22-4528, Sabouraud Agar with Chloramphenicol, Sabouraud Agar with Gentamicin and Chloramphenicol, Sabouraud GC Agar / BBL™ CHROMagar™ Candida Medium

   Based on customer feedback, BD has identified an outside supplier issue with this plate’s impregnated antibiotic, ...

   Waarschuwing | 06-09-2022

10. QIAGEN GmbH FSN_CI3026361- therascreen FGFR RGQ RT-PCR Kit

    QIAGEN heeft een verhoogd voorvalpercentage vastgesteld van fout-positieve resultaten met de therascreen FGFR RGQ RT-PCR Kit ...

    Waarschuwing | 12-08-2022