PlainRecalls

Ortho-Clinical Diagnostics, Inc.

Compiled from official public sources by the publisher.

90 recalls on record · Latest: Sep 24, 2025

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Agency notice ledger

Federal filing book Ortho-Clinical Diagnostics,… MID-BOOK · SINGLE-AGENCY

#194 of 14,151 · 90 notices · 0.086% archive

  • BOOK 90 notices
  • RANK #194 of 14,151
  • SHARE 0.086% archive
  • AGENCY FDA Devices (90)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 24, 2025
  • PHOTO Fresh Express Inc (Div

Nearest notice-volume peer: Fresh Express Inc (Div of Chiquita Brands) (0 notice gap)

Ortho-Clinical Diagnostics, Inc. accounts for about 0.086% of the 104,423-notice archive on 90 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Ortho-Clinical Diagnostics,… sits among 14,151 recalling firms

Ortho-Clinical Diagnostics, Inc. ranks 194th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Ortho-Clinical Diagnostics,… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

90 194th of 14151 higher than 13,956 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Ortho-Clinical Diagnostics,… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Ortho-Clinical Diagnostics, Inc. holds about 0.086% of archive notices alongside 90 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate May 31, 2023

VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
FDA Devices Moderate May 10, 2023

VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802413
FDA Devices Moderate May 10, 2023

VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6844461
FDA Devices Moderate May 10, 2023

VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802915
FDA Devices Moderate Apr 26, 2023

VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
FDA Devices Moderate Jan 11, 2023

VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
FDA Devices Moderate Nov 16, 2022

VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro diagnostic use only. Product Code: 8568040 . VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT
FDA Devices Moderate Sep 14, 2022

VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
FDA Devices Moderate Sep 14, 2022

VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
FDA Devices Moderate Jul 20, 2022

Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems. Product Code: 6199960
FDA Devices Moderate May 25, 2022

VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
FDA Devices Moderate May 25, 2022

VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
FDA Devices Moderate May 25, 2022

VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
FDA Devices Moderate Mar 16, 2022

VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
FDA Devices Moderate Jan 26, 2022

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack
FDA Devices Low Nov 24, 2021

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
FDA Devices Moderate Oct 27, 2021

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2. Product Code: 6199
FDA Devices Moderate Jun 2, 2021

VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
FDA Devices Moderate May 5, 2021

VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
FDA Devices Moderate Mar 31, 2021

VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Produc
FDA Devices Moderate Mar 24, 2021

VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. For emergency authorization use only (EAU). Product Code: 6199941. OUS Product.
FDA Devices Moderate Mar 24, 2021

VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) specimens. . For emergency authorization use only (EAU). Intended for Use in the United States Product Cod
FDA Devices Moderate Mar 3, 2021

VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Reagent Fluid into cuvettes in combination with sample fluid for Micro Tips Assays.
FDA Devices Moderate Jan 20, 2021

VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
FDA Devices Moderate Jan 20, 2021

VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
FDA Devices Moderate Jan 13, 2021

enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
FDA Devices Moderate Jan 13, 2021

VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.
FDA Devices Moderate Jan 13, 2021

VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cartridge) Product Code: 8001133 Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
FDA Devices Moderate Nov 25, 2020

VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier): 6199921 (10758750033355)
FDA Devices Moderate Nov 25, 2020

VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
FDA Devices Low Nov 25, 2020

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
FDA Devices Moderate Feb 19, 2020

VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
FDA Devices Moderate Jan 1, 2020

Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
FDA Devices Moderate Jan 1, 2020

7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Devices Moderate Feb 27, 2019

Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
FDA Devices Moderate Oct 10, 2018

VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
FDA Devices Moderate Oct 10, 2018

VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
FDA Devices Moderate Oct 10, 2018

VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
FDA Devices Moderate Oct 10, 2018

VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
FDA Devices Low Mar 7, 2018

VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Ortho-Clinical Diagnostics,… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (90 here — heavy-book).

Fresh Express Inc (Div of Chiquita Brands) 90 Tesla 90 American Surgical Company 91 Gills Onions, LLC 91 Mack 91

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

American Surgical Company 91 Medtronic Navigation, Inc. 91 Zimmer Manufacturing B.v. 91 Ge Healthcare 89

Frequently Asked Questions

How many federal recall notices name Ortho-Clinical Diagnostics,…? ▼
PlainRecalls indexes 90 distinct federal recall events naming Ortho-Clinical Diagnostics, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Ortho-Clinical Diagnostics,… sit among other recalling firms? ▼
Ortho-Clinical Diagnostics, Inc. ranks #194 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Ortho-Clinical Diagnostics,…'s notices? ▼
FDA Devices accounts for 90 of this firm's 90 indexed notices.
What product category dominates Ortho-Clinical Diagnostics,…'s filing book? ▼
Filings for Ortho-Clinical Diagnostics, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Ortho-Clinical Diagnostics, Inc.: 90 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Ortho-Clinical Diagnostics, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026