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 Sep 24, 2025

VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
FDA Devices Moderate Sep 24, 2025

Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.
FDA Devices Moderate Aug 27, 2025

VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
FDA Devices Moderate Jul 23, 2025

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: 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 Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabili
FDA Devices Moderate Jul 23, 2025

Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: 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 Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mprese
FDA Devices Moderate Jul 23, 2025

VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);
FDA Devices Moderate Jul 23, 2025

VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);
FDA Devices Moderate Jul 9, 2025

VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
FDA Devices Moderate Jul 9, 2025

Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
FDA Devices Moderate Jul 9, 2025

Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
FDA Devices Moderate Jul 9, 2025

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
FDA Devices Moderate Jun 18, 2025

Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software Version: not applicable Product Description: One sales unit (kit) contains materials for 48 tests. One kit contains 48 tubes of 1.45 mL Process Buffer and 48 Reaction Tubes. Component: No, not a component
FDA Devices Moderate Jun 4, 2025

VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
FDA Devices Moderate Jan 29, 2025

Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component
FDA Devices Moderate Jan 29, 2025

Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component
FDA Devices Moderate Jan 29, 2025

Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component
FDA Devices Moderate Dec 4, 2024

VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
FDA Devices Moderate Aug 28, 2024

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

FDA Devices Moderate Aug 21, 2024

VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Devices Low Jul 10, 2024

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
FDA Devices Moderate Jul 10, 2024

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.
FDA Devices Moderate Jun 19, 2024

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).
FDA Devices Low Jun 12, 2024

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
FDA Devices Moderate Mar 13, 2024

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS XT 7600 Integrated System, Catalog No. 6844461
FDA Devices Moderate Mar 13, 2024

VITROS 5600 Integrated System (New and Refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS XT7600 Integrated System
FDA Devices Moderate Mar 13, 2024

VITROS XT 3400 Chemistry System, Catalog No. 6844458
FDA Devices Moderate Mar 13, 2024

VITROS 3600 Immunodiagnostic System (New and Refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS XT 7600 Integrated System, Catalog No. 6844461
FDA Devices Moderate Mar 13, 2024

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
FDA Devices Moderate Mar 13, 2024

VITROS XT 3400 Chemistry System, Catalog No. 6844458
FDA Devices Moderate Jan 31, 2024

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
FDA Devices Moderate Jan 17, 2024

QMS Tacrolimus Calibrators, Product code 10015573
FDA Devices Moderate Dec 20, 2023

VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
FDA Devices Moderate Dec 20, 2023

VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
FDA Devices Moderate Dec 20, 2023

VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
FDA Devices Moderate Dec 20, 2023

VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
FDA Devices Moderate Dec 20, 2023

VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0
FDA Devices Moderate Dec 13, 2023

VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Product Code: 8262396
FDA Devices Moderate Nov 15, 2023

VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
FDA Devices Moderate Oct 11, 2023

Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrat
FDA Devices Moderate Sep 27, 2023

VITROS XT Chemistry Products ALKP Slides
FDA Devices Moderate Sep 27, 2023

VITROS XT Chemistry Products TBIL-ALKP Slides
FDA Devices Low Aug 2, 2023

VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. 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 N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
FDA Devices Moderate Jun 7, 2023

VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of vancomycin (VANC). Product Code: 6801696

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