PlainRecalls

Ortho-Clinical Diagnostics

Compiled from official public sources by the publisher.

221 recalls on record · Latest: Apr 3, 2024

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Agency notice ledger

Federal filing book Ortho-Clinical Diagnostics HEAVY-BOOK · SINGLE-AGENCY

#61 of 14,151 · 221 notices · 0.212% archive

  • BOOK 221 notices
  • RANK #61 of 14,151
  • SHARE 0.212% archive
  • AGENCY FDA Devices (221)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 3, 2024
  • PHOTO Biomet 3i, LLC

Nearest notice-volume peer: Biomet 3i, LLC (1 notice gap)

Ortho-Clinical Diagnostics accounts for about 0.212% of the 104,423-notice archive on 221 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 ranks 61st 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

221 61st of 14151 higher than 14,090 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 holds about 0.212% of archive notices alongside 221 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Apr 3, 2024

VITROS Performance Verifier I
FDA Devices Moderate Apr 3, 2024

VITROS Performance Verifier II
FDA Devices Moderate Aug 16, 2023

VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
FDA Devices Moderate Aug 16, 2023

VITROS Immunodiagnostic Products Troponin I ES Calibrators
FDA Devices Moderate Jul 19, 2023

VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code: 6801704
FDA Devices Moderate Sep 2, 2020

VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
FDA Devices Moderate Sep 2, 2020

VITROS XT7600 Integrated System, Product code 6844461
FDA Devices Moderate Sep 2, 2020

VITROS XT3400 Chemistry System, Product code 6844458
FDA Devices Moderate Sep 2, 2020

VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
FDA Devices Moderate Sep 2, 2020

VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
FDA Devices Moderate Aug 19, 2020

VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
FDA Devices Moderate Aug 19, 2020

VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
FDA Devices Moderate Jul 8, 2020

VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
FDA Devices Moderate Jul 8, 2020

VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
FDA Devices Moderate Jul 8, 2020

VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
FDA Devices Moderate Jul 8, 2020

VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
FDA Devices Moderate Jul 8, 2020

VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
FDA Devices Moderate Jun 24, 2020

VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # 10758750004577 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Devices Moderate Jun 24, 2020

VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Devices Moderate Jun 24, 2020

VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Devices Moderate Jun 24, 2020

VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code 8112724, UDI # 10758750004393 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
FDA Devices Moderate May 20, 2020

VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
FDA Devices Moderate May 20, 2020

VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Chemistry Product Slides are used to measure creatine kinase MB (CK-MB) activity in serum which used to be ordered to detect Myocardial Infarction.
FDA Devices Low May 6, 2020

VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
FDA Devices Moderate Nov 13, 2019

VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
FDA Devices Moderate Nov 13, 2019

VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain reagents in a dry, multi-layered form.
FDA Devices Moderate Nov 13, 2019

VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
FDA Devices Moderate Aug 14, 2019

VITROS 5600 Integrated System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems
FDA Devices Moderate Aug 14, 2019

VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 250AT Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 4600 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 4600 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 350 Chemistry System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS 5600 Integrated System, clinical chemistry analyzer
FDA Devices Moderate Aug 14, 2019

VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
FDA Devices Moderate Jul 10, 2019

VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
FDA Devices Moderate Jul 10, 2019

VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
FDA Devices Moderate Jul 10, 2019

VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
FDA Devices Moderate Jul 10, 2019

VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
FDA Devices Moderate May 29, 2019

VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
FDA Devices Moderate May 15, 2019

VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Devices Moderate May 15, 2019

VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Devices Moderate May 15, 2019

VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Devices Moderate May 15, 2019

VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
FDA Devices Moderate May 15, 2019

VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents

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 medical devices volume

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

Biomet 3i, LLC 222 Integra LifeSciences Corp. 217 DeRoyal Industries Inc 226 Resource Optimization & Innovation LLC 228

Frequently Asked Questions

How many federal recall notices name Ortho-Clinical Diagnostics? ▼
PlainRecalls indexes 221 distinct federal recall events naming Ortho-Clinical Diagnostics, 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 ranks #61 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 221 of this firm's 221 indexed notices.
What product category dominates Ortho-Clinical Diagnostics's filing book? ▼
Filings for Ortho-Clinical Diagnostics 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: 221 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; individual notices remain authoritative on each linked recall page.

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