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584 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. GENERI BIOTECH s.r.o., FSCA_UGT1A1_02_2022, gb PHARM UGT1A1

    An incorrectly determined genotype may affect the confirmation or exclusion of Gilbert syndrome. Based on the genotype ...

    Waarschuwing | 30-12-2022

  2. EPOCAL Inc., POC 23-004, Epoc Host 2 and Epoc NXS Host

    Siemens Healthcare Diagnostics Inc. has confirmed an issue through complaint investigation. The issue has the potential to affect ...

    Waarschuwing | 30-12-2022

  3. GENERI BIOTECH s.r.o, FSCA_UGT1A1_01_2022, gb PHARM UGT1A1

    The list of PCR cyclers in the User Manual contains incorrect information about the possibility of using the Rotor-Gene PCR ...

    Waarschuwing | 30-12-2022

  4. Ortho Clinical Diagnostics Inc, CL2022-298, ORTHO VISION and VISION Max Analyzers for BioVue

    The purpose of this notification is to inform you of a potential for false positive results during a probe replacement process ...

    Waarschuwing | 30-12-2022

  5. Randox Laboratories Ltd., REC629, Randox Specific Protein Control Levels 1-3

    Rheumatoid Factor (RF) is a protein whose levels are increased in patients with Rheumatoid Arthritis. Delay in reporting results ...

    Waarschuwing | 10-12-2022

  6. Oxoid Deutschland GmbH, FSN-, Columbia CAP Agar with Sheep Blood

    A technical investigation has concluded that Proteus spp grew and swarmed on the plate.  

    Waarschuwing | 13-10-2022

  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. bioMérieux FSCA 5690 - NUCLISENS® easyMAG® Magnetic Silica

    Following complaints from the field for contamination observed on extraction reagents with Legionella spp nucleic acids using ...

    Waarschuwing | 14-07-2022

  9. Roche Diagnostics CN-596638 - VENTANA HE 600 System

    Roche has confirmed 2 complaints regarding fluid leaks within the middle stainer module of the VENTANA HE 600 that likely ...

    Waarschuwing | 30-06-2022

  10. Thermo Fisher Scientific, FSN-2022-006, Thermo Scientific IDEIA Lyme Neuroborreliosis

    An internal technical investigation has determined that when testing at 20°C, K602811-2 IDEIA Lyme Neuroborreliosis Lots. ...

    Waarschuwing | 24-06-2022

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