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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
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range.
FDA Recall
Open, Classified
·IN MY BATHROOM LLC·Product code RHP·January 27, 2022
PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493
FDA Recall
Open, Classified
·CP Medical Inc·Product code GAM·February 2, 2017
Alinity m System, Part No. 08N53-002
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code MZP·December 6, 2021
Alinity m System, Part No. 08N53-002
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code MZP·December 6, 2021
Alinity m System, Part No. 08N53-002
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code MZP·December 6, 2021
Ascom Telligence Nurse Call System
FDA Recall
Open, Classified
·Ascom (US) Inc.·Product code IQA·November 2, 2018
Seca 402/403 Baby Scale Cart, Ref # 4020000009/ REF # 4030000009
FDA Recall
Open, Classified
·Seca Hammer Steindamm 9-25 Hamburg Germany·Product code FRW·June 19, 2019
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEX·December 4, 2023
Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
FDA Recall
Open, Classified
·Tollos·Product code FNG·October 24, 2022
Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
FDA Recall
Open, Classified
·Hager & Meisinger Gmbh Ronsdorferstrasse 22 Dusseldorf Germany·Product code EJL·November 7, 2018
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code MVR·December 28, 2020
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
FDA Recall
Open, Classified
·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023
Model No. CYF-5, Cystonephrofiberscope
FDA Recall
Open, Classified
·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023
Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
FDA Recall
Open, Classified
·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code EOQ·December 4, 2023
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
FDA Recall
Open, Classified
·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code NWB·May 5, 2025
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
FDA Recall
Open, Classified
·Hologic, Inc.·Product code NJR·December 13, 2024
Model No. CYF-5R, Cystonephrofiberscope
FDA Recall
Open, Classified
·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
FDA Recall
Open, Classified
·Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan·Product code FAJ·December 4, 2023