Device manufacturer, as written on reports

Ortho-Clinical Diagnostics: medical device reports filed with FDA

14,543 reports name it as the manufacturer of the device involved, 1997–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

14,543
reports naming it as manufacturer: 0.1% of all MAUDE reports; 486
reports, 12 months to August 2026: 416 in the 12 months before; 97.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

14,543 medical device reports received by FDA give Ortho-Clinical Diagnostics as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 1997 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

486 reports arrived in the 12 months to August 2026, up 17% from 416 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (97.9%), other (1.4%) and injury (0.6%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
VITROS 5600 Integrated System	Analyzer, chemistry (photometric, discrete), for clinical use	881	19	0%
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack	Immunoassay method, troponin subunit	874	52	0%
VITROS Chemistry Products PHYT Slides	Enzyme immunoassay, diphenylhydantoin	745	8	0%
Vitros Immunodiagnostic Products Tsh Reagent Pack	Radioimmunoassay, thyroid-stimulating hormone	516	32	0%
Vitros Eci Immunodiagnostic System	Analyzer, chemistry (photometric, discrete), for clinical use	480	0	0%
Vitros 5 1 Fs Chemistry System	Analyzer, chemistry (photometric, discrete), for clinical use	454	0	0%
Vitros Chemistry Products Phbr Slides	Enzyme immunoassay, phenobarbital	430	6	0%
Vitros Eci Immunodiagnostic Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	427	0	0%
Vitros Eciq Immunodiagnostic System	Fluorometer, for clinical use	385	0	0%
Ortho Summit Sample Handling System	Device, microtiter diluting/dispensing	362	0	0%
Vitros Immunodiagnostic Products Intact Pth Reagent Pack	Radioimmunoassay, parathyroid hormone	356	3	0%
VITROS Chemistry Products Na+ Slides	Electrode, ion specific, sodium	316	61	0%
0 8% Resolve Panel A	System, test, automated blood grouping and antibody	295	0	0%
Vitros 250 Chemistry System	Analyzer, chemistry (photometric, discrete), for clinical use	259	0	0%
VITROS Chemistry Products VALP Reagent	Enzyme immunoassay, valproic acid	257	4	0%
Vitros 350 Chemistry System	Analyzer, chemistry (photometric, discrete), for clinical use	215	3	0%
Vitros Chemistry Products Amon Slides	—	192	15	0%
Vitros Immunodiagnostic Products Troponin I Es Reagent	Immunoassay method, troponin subunit	189	0	0%
Vitros Chemistry Products Glu Slides	Glucose oxidase, glucose	185	3	0%
VITROS Chemistry Products CREA Slides	Enzymatic method, creatinine	175	20	0%
Vitros Immunodiagnostics Products Tropi Es Reagent Pack	Immunoassay method, troponin subunit	163	0	0%
0 8% Surgiscreen	System, test, automated blood grouping and antibody	146	0	0%
0 8% Selectogen	System, test, automated blood grouping and antibody	137	0	0%
Ortho Summit Sample Handler	Device, microtiter diluting/dispensing	73	0	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
JJE	Analyzer, chemistry (photometric, discrete), for clinical use	3,582	24.6%
MMI	Immunoassay method, troponin subunit	1,991	13.7%
KSZ	System, test, automated blood grouping and antibody	1,080	7.4%
JTC	Device, microtiter diluting/dispensing	1,014	7%
DIP	Enzyme immunoassay, diphenylhydantoin	835	5.7%
JLW	Radioimmunoassay, thyroid-stimulating hormone	705	4.8%
LOM	Test, hepatitis b (b antigen, b surface antigen, be antigen)	425	2.9%
CEW	Radioimmunoassay, parathyroid hormone	379	2.6%
DLZ	Enzyme immunoassay, phenobarbital	362	2.5%
KHO	Fluorometer, for clinical use	349	2.4%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0%2

Injury0.6%84

Malfunction97.9%14,243

Other1.4%203

Not given0.1%11

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Ortho-Clinical Diagnostics reports

How many FDA device reports name Ortho-Clinical Diagnostics as manufacturer?

14,543 reports through August 2026, 486 of them in the latest 12 months.

Which of its brands appear most often?

VITROS 5600 Integrated System (881), VITROS Immunodiagnostic Products Troponin I ES Reagent Pack (874), VITROS Chemistry Products PHYT Slides (745), Vitros Immunodiagnostic Products Tsh Reagent Pack (516) and Vitros Eci Immunodiagnostic System (480).

Which device types does it report on?

analyzer, chemistry (photometric, discrete), for clinical use (24.6%), immunoassay method, troponin subunit (13.7%), system, test, automated blood grouping and antibody (7.4%) and device, microtiter diluting/dispensing (7%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.