Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. DiaMed, FSCA 001-23, IH-1000

   When one or multiple Crossmatch tests and Auto control tests are requested in IH-Com, under certain circumstances described ...

   Waarschuwing | 14-02-2023

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. 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

4. Abbott GmbH FA09JUN2022 - ARCHITECT and Alinity c Hemoglobin A1c (Reagent Kit)

   This letter is to inform you of a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c patient results to be ...

   Waarschuwing | 09-06-2022

5. Abbott GmbH, FSN-FA28APR2022_06P01-55, Alinity s HIV Ag/Ab Combo Reagent Kit

   Abbott has identified a potential issue with Alinity s System software versions 2.8.0 and prior. Abbott is releasing Alinity s ...

   Waarschuwing | 20-05-2022

6. Siemens Healthcare Diagnostics Inc, FSN-ACHC 22-02, Lithium_2 (LITH_2) reagents, Enzymatic Hemoglobin A1c (A1c_E) reagents, Calcium_2 (CA_2) reagents, Fructosamine (Fruc) reagents

   Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient ...

   Waarschuwing | 24-02-2022

7. Trinity Biotech plc R015-21 - Menarini Premier Hb9210 Diluent Reagent

   Menarini Premier Hb9210 Diluent Reagent voldoet voor een aantal partijen niet aan de geclaimde houdbaarheidsperiode van 12 ...

   Waarschuwing | 31-01-2022

8. Chromsystems Instruments & Chemicals GmbH FSN 1-2022 - Analytical column MassChrom® Free Metanephrines in plasma

   When using batches of the column 81100 listed in Table 1, a decrease in the intensity of both the analyte and Internal Standard ...

   Waarschuwing | 31-01-2022

9. PerkinElmer Wallac Oy IT2056451 - PerkinElmer DELFIA® Xpress

   We have become aware that the measured analyte concentrations in occasional patient samples may be decreased with DELFIA® Xpress ...

   Waarschuwing | 05-01-2022

10. BioFire Diagnostics_bioMérieux FSCA 5323 - BioFire BCID2 Panel

    Met deze brief willen wij u informeren dat BioFire Diagnostics, LLC, een dochteronderneming van bioMérieux, een verhoogd risico ...

    Waarschuwing | 09-11-2021