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  1. Abbott, FA05MAY2022, Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module

    Abbott Hematology is releasing new software version 5.0 for the Alinity h-series.

    Waarschuwing | 18-05-2022

  2. Biomedical Data Solutions FSCA 64581 - Ortho Connect

    It has been identified that an end user site had attempted to perform QC on a single test using multiple QC kits. The Quality ...

    Waarschuwing | 18-05-2022

  3. Siemens Healthcare Diagnostics PH-22-005-A-C - INNOVANCE D-Dimer Controls

    The purpose of this communication is to inform you about the potential risk of allergic skin reactions in case of direct skin ...

    Waarschuwing | 18-05-2022

  4. Haemonetics Corporation, FSN-FSCA-FY23-02, Functional Fibrinogen Kit

    Haemonetics has identified a shift in the citrated blood reference range for a normal population. Due to this shift, the ranges ...

    Waarschuwing | 13-05-2022

  5. Illumina, QI-000509, NextSeq 550Dx

    Illumina heeft een probleem vastgesteld dat kortsluiting kan veroorzaken in de behuizing van het instrument.

    Waarschuwing | 31-03-2022

  6. 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

  7. 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

  8. 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

  9. Siemens Healthcare Diagnostics, ASW 22-01, Atellica CH 930 Analyzer

    Siemens Healthcare Diagnostics has identified issues with the Atellica Solution products listed in Table 1, which are installed ...

    Waarschuwing | 07-01-2022

  10. Abbott FA-AM-DEC2021-264 - Alinity m system

    Abbott Molecular Inc. has received two customer reports of Alinity m Resp-4-Plex false positive results and two customer reports ...

    Waarschuwing | 06-01-2022

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