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  1. Abbott Molecular, Inc., FSN-FA-AM-OCT2022-282, Alinity m System

    This letter contains important information regarding your Alinity m System; Specifically, the current software installed on your ...

    Waarschuwing | 15-11-2022

  2. Leica Biosystems Nussloch GmbH, FSN-NCMR: 200100198, Leica Biosystems Tissue processor, HistoCore SPECTRA ST

    As part of our post market surveillance, we have identified 7 vulnerabilities affecting the PTC (Parametric Technology ...

    Waarschuwing | 08-06-2022

  3. DNA Genotek, 200018182, ORAcollect DNA / ORAcollect RNA / ORAcollect Dx

    As a result, in a small subset of products, the amount of available stabilizing liquid may be lower than expected.

    Waarschuwing | 20-04-2022

  4. Abbott Molecular FA-AM-MAR2022-269 - Alinity m HBV AMP Kit

    Abbott has received reports of falsely elevated results when using the Alinity m HBV AMP Kit. Data analysis has determined that ...

    Waarschuwing | 28-03-2022

  5. SENTINEL FSCA 01/2022 - CALiaGOLD Control Set

    An accuracy issue using Sentinel CALiaGold® Control Set REF 1151200 has been encountered, when testing the control material, ...

    Waarschuwing | 28-03-2022

  6. CareDx AB FSN 2021-06 - SCORE 6

    SCORE 6 sometimes incorrectly sets the Cq value to 0 (zero), which is interpreted as a negative call, for curves that have an ...

    Waarschuwing | 14-12-2021

  7. Randox Laboratories Ltd, FSN-REC527, Randox NEFA (Non-esterified fatty acid)

    Randox can confirm the NEFA standard 522FA packed within NEFA kit Catalogue Number FA115 Batch 544642 has been assigned ...

    Waarschuwing | 20-05-2021

  8. The Binding Site Group Limited, FSN-AE051, Optilite Freelite Kappa Free Kits

    The Binding Site Group Limited meldt veiligheidsbericht over de Optilite Freelite Kappa Free Kits.

    Waarschuwing | 02-12-2020

  9. 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

  10. Gentian AS CC-167 - Gentian Cystatin C Calibrator and Calibrator Kit

    The identified lots of calibrators have shown to measure incorrect high values over time compared to the assigned values when ...

    Waarschuwing | 02-09-2020

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