Fluorometer, for clinical use: medical device reports filed with FDA

4,533 reports carry this product code, 1998–2026; 7 brands with a page.

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.

4,533
reports with this product code: 0% of all MAUDE reports; 175
reports, 12 months to August 2026: 184 in the 12 months before; 99.2%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code KHO is FDA's classification for "Fluorometer, for clinical use" (clinical Chemistry panel), a class 1 device. 4,533 medical device reports carry this product code, 0% of the MAUDE database, from October 1998 to August 2026.

175 reports arrived in the 12 months to August 2026, close to the 184 of 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 (99.2%), injury (0.5%) and other (0.3%). 7 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Aia-900	1,351	71	0%	100%
Aia-360	1,019	42	0%	100%
Aia-2000	962	57	0%	99.9%
Vitros Eciq Immunodiagnostic System	205	0	0%	99.2%
Vitros Eci Immunodiagnostic System	94	0	0%	99.6%
Vitros Eci Immunodiagnostic Analyzer	14	0	0%	100%
Vitros 350 Chemistry System	1	3	0%	100%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Tosoh	2,744	60.5%
Tosoh Hi-Tec	1,003	22.1%
Ortho-Clinical Diagnostics	349	7.7%
Biosite	6	0.1%
Ortho Clinical Diagnostics	4	0.1%
Alere San Diego	3	0.1%
Dade Behring	2	0%

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 and report source

Event type

Death0%0

Injury0.5%23

Malfunction99.2%4,495

Other0.3%14

Not given0%1

Who filed

Manufacturer report99.2%4,498

Voluntary report0.2%11

User facility report0%0

Distributor report0.5%24

Not given0%0

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Mechanical problema mechanical problem	1,431	31.6%
Device displays incorrect message	889	19.6%
Device operates differently than expectedthe device behaved unexpectedly	645	14.2%
Device operational issue	542	12%
Incorrect, inadequate or imprecise result or readings	509	11.2%
Device issuea problem with the device	372	8.2%
High test results	201	4.4%
Incorrect or inadequate test results	125	2.8%
Imprecision	75	1.7%
Electrical /electronic property probleman electrical or electronic problem	64	1.4%
Failure to align	62	1.4%
Output problem	57	1.3%
Low test results	51	1.1%
Maintenance does not comply to manufacturers recommendations	49	1.1%
False reading from device non-compliance	47	1%
High readingsreadings were too high	45	1%
Obstruction of flow	40	0.9%
Display or visual feedback problem	31	0.7%
Computer software problema software problem	30	0.7%
Leak/splashthe device leaked	30	0.7%

Questions about fluorometer, for clinical use reports

What is product code KHO?

FDA's classification code for "Fluorometer, for clinical use", class 1, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,533 reports through August 2026, 175 of them in the latest 12 months.

Which brands appear most often?

Aia-900 (1,351), Aia-360 (1,019), Aia-2000 (962), Vitros Eciq Immunodiagnostic System (205) and Vitros Eci Immunodiagnostic System (94). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.