Ortho Clinical Diagnostics
FDA Regulatory Profile
Ortho Clinical Diagnostics appears in FDA public data with 38 recalls, 16 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0120-2022, Class II) was initiated on September 10, 2021. Its most recent 510(k) clearance was granted on August 28, 2024.
Summary
- Total Recalls
- 38
- 510(k) Clearances
- 16
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0120-2022 | Class II | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monito | September 10, 2021 |
| Z-0844-2021 | Class II | VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasm | December 15, 2020 |
| Z-0845-2021 | Class II | VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total | December 15, 2020 |
| Z-0770-2021 | Class II | VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8 | December 11, 2020 |
| Z-0471-2021 | Class III | VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry | October 16, 2020 |
| Z-0450-2021 | Class II | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA | September 30, 2020 |
| Z-0451-2021 | Class II | VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring | September 30, 2020 |
| Z-2879-2020 | Class II | VITROS XT7600 Integrated System, Product code 6844461 | July 20, 2020 |
| Z-2878-2020 | Class II | VITROS XT3400 Chemistry System, Product code 6844458 | July 20, 2020 |
| Z-2771-2020 | Class II | VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750 | July 17, 2020 |
| Z-2770-2020 | Class II | VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033 | July 17, 2020 |
| Z-2482-2020 | Class II | VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Id | May 20, 2020 |
| Z-2483-2020 | Class II | VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 68029 | May 20, 2020 |
| Z-2484-2020 | Class II | VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Uniq | May 20, 2020 |
| Z-2480-2020 | Class II | VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique | May 20, 2020 |
| Z-2481-2020 | Class II | VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 107587 | May 20, 2020 |
| Z-1834-2020 | Class III | VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 | March 10, 2020 |
| Z-1226-2020 | Class II | VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 C | December 16, 2019 |
| Z-0740-2020 | Class II | Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for | October 14, 2019 |
| Z-0739-2020 | Class II | 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when | October 14, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | August 28, 2024 |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | May 8, 2024 |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | September 5, 2023 |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | August 23, 2023 |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | August 9, 2023 |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | December 12, 2022 |
| K213626 | VITROS AFP | June 15, 2022 |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | January 28, 2022 |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | October 4, 2021 |
| K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | February 25, 2020 |
| K163433 | VITROS Chemistry Products GLU Slides | September 18, 2017 |
| K160712 | VITROS Chemistry Products hsCRP Reagent | July 14, 2017 |
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | May 16, 2017 |
| K162020 | VITROS Chemistry Products Cl- Slides | December 16, 2016 |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 | September 24, 2015 |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A | June 4, 2015 |