Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Siemens Healthcare, PH-20-001, Thromborel S

    Siemens Healthcare Diagnostics Products GmbH has confirmed that Thromborel S lot 565662 is showing a decreased on-board stability ...

    Waarschuwing | 06-11-2019

  2. Beckman Coulter, FA-000152, iQ200 Series Urine Microscopy Analyzer, iChemVELOCITY Urine Chemistry System

    Klanten hebben incidenten gemeld waarbij twee resultaatreeksen dezelfde monsteridentificatiecode (monster-ID) rapporteren met ...

    Waarschuwing | 04-11-2019

  3. Radiometer Medical, FAN 915-402, AQT90 FLEX analyzer

    Radiometer has become aware that certain Lots of Cleaning Solution tubes for the AQT90 FLEX has been produced with an incorrect ...

    Waarschuwing | 30-10-2019

  4. bioMérieux SA, FSCA 4553, Cetrimide Agar

    Based on the investigation results, there is a potential risk for False negative results for Pseudomonas aeruginosa with lot. # ...

    Waarschuwing | 29-10-2019

  5. Randox Laboratories, REC414, Liquid Cardiac Controls

    Randox has observed a decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots of Liquid ...

    Waarschuwing | 01-10-2019

  6. Beckman Coulter Ireland, FA-000082, iChemVELOCITY-urineteststrips

    Update de standaardwerkvoorschriften en het trainingsmateriaal van uw laboratorium om onderstaande herziene leukocytenbeperkingen ...

    Waarschuwing | 30-09-2019

  7. DIALAB, Diacon P 2019-09, Diacon P

    The values for parameters Zine an Cooper of the package insert of the concerned lot of control show wrong data.

    Waarschuwing | 25-09-2019

  8. Randox Laboratories Ltd REC422 NEFA

    Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 shows a positive shift in recovery for patient samples of approximately 10% ...

    Waarschuwing | 23-09-2019

  9. HemoCue AB FA-0031 Glucose monitoring system IVD, point-of-care

    HemoCue has become aware that the HemoCue 201 DM - DMS Software includes old revisions of Analyzer lnstructions for Use and ...

    Waarschuwing | 10-09-2019

  10. bioMerieux, FSCA 4449, A7 Mycoplasma Agar (MYCO)

    Following an internal study, stability issues were observed on the product A7 Mycoplasma Agar after thermal shock, leading to ...

    Waarschuwing | 05-09-2019