Ortho-Clinical Diagnostics, Inc.: Medical Device Recalls in 2024

According to to data from the FDA, there were 22 medical device recalls made by Ortho-Clinical Diagnostics, Inc. in 2024. See the details of the recalls below.

You can see similar recalls for other firms.

• VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
• VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
• VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
• VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
• VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
• VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
• VITROS 5600 Integrated System (New and Refurbished)
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
• VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
• VITROS XT 7600 Integrated System, Catalog No. 6844461
• VITROS XT7600 Integrated System
• VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
• VITROS XT 3400 Chemistry System, Catalog No. 6844458
• VITROS XT 3400 Chemistry System, Catalog No. 6844458
• VITROS XT 7600 Integrated System, Catalog No. 6844461
• VITROS 3600 Immunodiagnostic System (New and Refurbished)
• QMS Tacrolimus Calibrators, Product code 10015573
• VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
• VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344
• 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