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Sources: EU EUDAMED, US FDA
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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
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
FDA Recall
Open, Classified
·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code CKB·April 30, 2025
VITROS XT Chemistry Products ALKP Slides
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code CJE·August 5, 2023
VITROS XT Chemistry Products TBIL-ALKP Slides
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, INc.·Product code CIG·August 5, 2023