Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Abbott Molecular, Inc., FSN-FA-AM-FEB2022-267, Integrated Reaction Unit (IRU)

   Abbott has received complaints associated with the Alinity m Reaction Vessels (RVs) detaching from the RV Cap during transport by ...

   Waarschuwing | 24-02-2022

2. BioMérieux SA, FSN-FSCA 5537, VIDAS® CMV IgM

   BioMérieux received complaints about calibration issue observed on VIDAS® CMV IgM (ref 30205, 30205-01), Lot 1008873250 and Lot ...

   Waarschuwing | 24-02-2022

3. 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

4. Siemens Healthcare Diagnostics Inc, FSN-VC 22-01, Dimension Vista Magnesium Flex reagent cartridge

   Siemens Healthineers has confirmed that the Dimension Vista Magnesium (MG) Flex reagent cartridge lots listed in Table 1 may show ...

   Waarschuwing | 24-02-2022

5. Hologic FA-00197 - PANTHER FUSION EXTRACTION REAGENT-X kit

   When the Panther Fusion Capture Reagent-X has been stored at 28^oC or higher and is used to expiration, there is a possibility for ...

   Waarschuwing | 23-02-2022

6. Abbott FA03FEB2022 - Alinity s System

   Abbott has identified an error associated with the reagent probe (R1) wash cycle introduced in the Alinity s System software (SW) ...

   Waarschuwing | 23-02-2022

7. Bio-Rad_DiaMed GmbH FSCA 003-21 - ID-DiaCell I-II-III and ID-DiaCell IP-IIP-IIIP

   Further to customer reports, we have been able to confirm that marked hemolysis can be observed with the ID-DiaCell I-II-III and ...

   Waarschuwing | 16-02-2022

8. 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

9. 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

10. Ventana Medical Systems Inc, FSN-CN-583565 (SBN-RDS-PathologyLab-2022-001), BENCHMARK ULTRA

    Roche received a complaint reporting a fluid leak within the BenchMark ULTRA instrument that created an electrical short inside ...

    Waarschuwing | 20-01-2022