BEUDAMED
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    VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·July 19, 2022

    VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJE·July 19, 2022

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID

    FDA Recall
    Open, Classified ·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID

    FDA Recall
    Open, Classified ·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024

    Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID

    FDA Recall
    Open, Classified ·Nova Ortho-Med Inc·Product code ITJ·August 26, 2024

    YSIO X.Pree

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code KPR·March 7, 2022

    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromocresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample. Model/Catalog Number: 6844293

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code CIX·July 10, 2024