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  1. Randox Laboratories Ltd., FSN-REC679, LIQUID URINE CONTROL LEVEL 2

    Randox Laboratories is conducting a Device Recall for Liquid Urine Controls Level 2, UC5074, lot 1209UC due to the following:  ...

    Waarschuwing | 24-07-2023

  2. HYPHEN BioMed, FSN-FSCA29, BIOPHEN TM Protein C LRT

    The R2 of the products listed above contains Cesium Chlodride. Following information from our supplier, this substance has ...

    Waarschuwing | 16-03-2023

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

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