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  1. Abbott Diagnostics Technologies AS, FSN-CAPA-00005233, Alere Afinion 2 Afinion 2

    Abbott has identified an issue related to overheating of Afinion 2 instruments with software version ≤ 21.13. 

    Waarschuwing | 08-06-2023

  2. Waters Corporation, 1218959-11.17.2021-003-C, Waters 3777C Sample Manager IVD

    After investigation, a defect has been found that can result in a single sample being injected and recorded against the incorrect ...

    Waarschuwing | 26-04-2023

  3. Beckman Coulter Ireland Inc., 000884, Bicarbonate

    Beckman Coulter has confirmed a premature decrease in calibratior ODs for the following lots of Bicarbonate OSR6x90.

    Waarschuwing | 20-04-2023

  4. R&R Mechatronics International B.V., Klaud nr.153, Starrsed Control

    It has been brought to our attention that there is a small amount of vails of QRR049001 Lot QCAB6AN505 incorrectly labelled as ...

    Waarschuwing | 18-04-2023

  5. Ortho Clinical Diagnostics Inc, CL2023-065, ORTHO BioVue Cassettes

    Tijdens een routinematige interne inspectie heeft Ortho een rood/bruin residu in de reactiekamer/-kolom van de cassette ...

    Waarschuwing | 17-04-2023

  6. Beckman Coulter, 23001, Access 2 Immunoassay-analyser, Access 2-gedeelte, DxC 600i

    Beckman Coulter heeft vastgesteld dat de draadschroefmoerband van de wasarm van de Access-2 breukgevoelig is.

    Waarschuwing | 15-02-2023

  7. BioMérieux SA, FSN-FSCA 5742-1, MUELLER HINTON E AGAR

    Following customer complaints, a performance limitation with the combination Pseudomonas aeruginosa - Gentamicin on MUELLER ...

    Waarschuwing | 02-02-2023

  8. Siemens Healthcare Diagnostics Inc, IMC 23-04, IMMULITE® 2000 Thryoglobulin

    The purpose of this communication is to inform you of an issue with the product indicated in Table 1 above and provide ...

    Waarschuwing | 30-12-2022

  9. Leica Biosystems Newcastle, IR 66/22, NovocastraTM Muscle Specific Actin

    Leica Biosystems Newcastle recently became aware the IFU of affected device mentioned above incorrectly states a suggested ...

    Waarschuwing | 15-12-2022

  10. Abbott Molecular, FA-AM-NOV2022-283, Alinity m Resp-4-Plex AMP Kit

    Abbott has received reports of an increase in reactive negative controls and false positive results, with certain lots of Alinity ...

    Waarschuwing | 09-12-2022

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