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  1. Hitachi High Technologies Corporation (HHT), FSN-CN-509982,CN-530429 (SBN-CPS- 2020-013), cobas 8000 Core Unit,cobas pro sample supply unit,cobas c 513 analyzer commercial system

    Roche has received one customer complaint for the cobas 8000 modular analyzer series where due to a software limitation the ...

    Waarschuwing | 30-11-2020

  2. DiaSorin Ine. US, FSN-WS1000069, LIAISON® 1-84 PTH Assay

    DiaSorin has confirmed that the LIAISON® 1-84 PTH Assay {REF 310630) lot numbers 134909, 134909A and 1349098, may produce falsely ...

    Waarschuwing | 27-11-2020

  3. Siemens Healthcare Diagnostics Inc., FSN-ACHC 21-01, Triglyceride IVD, kit, enzyme spectrophotometry

    Siemens Healthcare Diagnostics Inc. has become aware that falsely depressed results may be observed in the presence of ...

    Waarschuwing | 26-11-2020

  4. IQ Products BV, FSN-FSCA-2020-01- INC323, FMH QuikQuant

    IQ Products BV meldt Filed Safety over FMH QuikQuant.

    Waarschuwing | 26-11-2020

  5. Roche Molecular Systems, FSN-CN-516475, cobas z 480 analyzer

    Roche received complaint cases alleging false positive or invalid results with select cobas® 4800 IVD assays.

    Waarschuwing | 24-11-2020

  6. Siemens Healthcare Diagnostics Inc., FSN-ASW21-01, Atellica IM 1300 Analyzer and Atellica IM 1600

    Siemens Healthcare Diagnostics has identified an issue with the Atellica Solution products  through investigation of customer ...

    Waarschuwing | 18-11-2020

  7. Abbott GmbH, FSN-FA12NOV2020, ARCHITECT Active-B12 (Holotranscobalamin) Reagent, Calibrators, Controls; Alinity i Active-B12 (Holotranscobalamin) Reagent, Calibrators, Controls

    The purpose of this letter is to inform you of a product recall for the reformulated Alinity i/ARCHITECT Active‐B12 product.  

    Waarschuwing | 13-11-2020

  8. Chromsystems Instruments & Chemicals GmbH, FSN-2-2020, 6PLUS1 Multilevel Saliva Calibrator Set

    Chromsystems Instruments & Chemicals GmbH meldt Field Safety over 6PLUS1 Multilevel Saliva Calibrator Set.

    Waarschuwing | 12-11-2020

  9. bioMérieux SA, FSN-FSCA 4924, VIDAS® FT4

    URGENT FIELD SAFETY NOTICE VIDAS® FT4

    Waarschuwing | 12-11-2020

  10. SENTINEL CH. S.p.A, FSN-07/2020, Zine

    This letter contains important information regarding the ZINC product REF 17640H lot 90227.

    Waarschuwing | 30-10-2020

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