Ortho-Clinical Diagnostics, Inc.
Summary
- Total Recalls
- 273
- 510(k) Clearances
- 128
- Inspections
- 22
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2559-2025 | Class II | Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 s | July 29, 2025 |
| Z-2560-2025 | Class II | VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges | July 29, 2025 |
| Z-2335-2025 | Class II | VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261; | July 9, 2025 |
| Z-2073-2025 | Class II | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual | June 12, 2025 |
| Z-2123-2025 | Class II | VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 41 | June 10, 2025 |
| Z-2121-2025 | Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier | June 10, 2025 |
| Z-2122-2025 | Class II | VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 | June 10, 2025 |
| Z-2120-2025 | Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier | June 10, 2025 |
| Z-2040-2025 | Class II | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, ( | May 9, 2025 |
| Z-2038-2025 | Class II | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, | May 9, 2025 |
| Z-2039-2025 | Class II | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844 | May 9, 2025 |
| Z-1876-2025 | Class II | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartrid | April 14, 2025 |
| Z-1948-2025 | Class II | Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Nu | March 24, 2025 |
| Z-1007-2025 | Class II | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 | December 19, 2024 |
| Z-1005-2025 | Class II | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New) | December 19, 2024 |
| Z-1006-2025 | Class II | Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (N | December 19, 2024 |
| Z-0535-2025 | Class II | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein | October 11, 2024 |
| Z-2684-2024 | Class II | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test | July 10, 2024 |
| Z-2580-2024 | Class II | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 | July 3, 2024 |
| Z-2266-2024 | Class II | VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VI | May 21, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | October 29, 2025 |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products | May 5, 2023 |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Product | May 5, 2023 |
| K210858 | VITROS Chemistry Products PHBR Slides | August 13, 2021 |
| K191316 | VITROS XT Chemistry Products ALB-TP Slides | June 7, 2019 |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides | April 26, 2019 |
| K190520 | VITROS XT Chemistry Products GLU-Ca Slides | April 3, 2019 |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL Slides | March 27, 2019 |
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | March 14, 2019 |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Product | October 30, 2018 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Produ | October 30, 2018 |
| K160495 | VITROS® Automation Solutions | October 18, 2016 |
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | May 20, 2016 |
| K130332 | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | May 31, 2013 |
| K123930 | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND II | May 15, 2013 |
| K121608 | VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS | February 15, 2013 |
| K120765 | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | October 24, 2012 |
| K120609 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES | September 7, 2012 |
| K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT | October 22, 2010 |
| K093611 | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT | April 15, 2010 |