Device manufacturer, as written on reports

Beckman Coulter: medical device reports filed with FDA

51,941 reports name it as the manufacturer of the device involved, 1999–2026.

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.

51,941
reports naming it as manufacturer: 0.2% of all MAUDE reports; 656
reports, 12 months to August 2026: 750 in the 12 months before; 91%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

51,941 medical device reports received by FDA give Beckman Coulter as the manufacturer of the device involved, 0.2% of the MAUDE database, from April 1999 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

656 reports arrived in the 12 months to August 2026, down 13% from 750 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 (91%), injury (4.8%) and other (3.5%). 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
Access 2 Immunoassay System	Analyzer, chemistry (photometric, discrete), for clinical use	4,712	0	0%
Unicel Dxi 800 Access Immunoassay System	Analyzer, chemistry (photometric, discrete), for clinical use	3,125	0	0%
UniCel DxC 600i SYNCHRON Access Clinical System	Analyzer, chemistry (photometric, discrete), for clinical use	2,962	13	0%
Coulter Lh 750 Hematology Analyzer	Counter, differential cell	2,730	0	0%
Unicel Dxc 800 Synchron System	Analyzer, chemistry (photometric, discrete), for clinical use	2,230	0	0%
Coulter Lh 500 Hematology Analyzer	Counter, differential cell	2,009	0	0%
Coulter Lh 780 Hematology Analyzer	Counter, differential cell	1,597	0	0%
Unicel Dxh 800 Coulter Cellular Analysis System	Counter, differential cell	1,591	0	0%
Fc 500 Flow Cytometer	Counter, differential cell	1,185	0	0%
Unicel Dxc 600 Synchron System	Analyzer, chemistry (photometric, discrete), for clinical use	1,151	0	0%
AU5800 Clinical Chemistry Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	1,078	69	0%
Unicel Dxc 800 Pro Synchron Chemistry Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	865	0	0%
Coulter Hmx Hematology Analyzer With Autoloader	Counter, differential cell	691	0	0%
Unicel Dxc 800 Synchron Clinical System	Analyzer, chemistry (photometric, discrete), for clinical use	649	0	0%
Unicel Dxc 600 Synchron Clinical System	Analyzer, chemistry (photometric, discrete), for clinical use	635	0	0%
AU5800 Chemistry Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	611	74	0%
Access Accutni+3 Reagent	Immunoassay method, troponin subunit	577	4	0%
Unicel Dxc 600 Pro Synchron Chemistry Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	564	0	0%
Unicel Dxl 800 Access Immunoassay System	Analyzer, chemistry (photometric, discrete), for clinical use	542	0	0%
AU680 Clinical Chemistry Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	518	15	0.2%
Coulter Act Diff 2 Analyzer	Counter, differential cell	474	0	0%
AU480 Clinical Chemistry Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	469	55	0%
Coulter Act Diff Analyzer	Counter, differential cell	432	0	0%
Unicel Dxc 600 Pro Synchron System	Analyzer, chemistry (photometric, discrete), for clinical use	428	0	0%
Unicel Dxc 800 Pro Synchron Clinical System	Analyzer, chemistry (photometric, discrete), for clinical use	408	0	0%
Coulter Ac T Diff Analyzer	Counter, differential cell	406	0	0%
Synchron Lx I 725 Clinical System	Analyzer, chemistry (photometric, discrete), for clinical use	394	0	0%
Coulter Ac T Diff 2 Analyzer	Counter, differential cell	388	0	0%
DxC 700 AU Clinical Chemistry Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	360	85	0.3%
Access 2 Immunoassay Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	335	13	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	24,176	46.5%
GKZ	Counter, differential cell	16,128	31.1%
MMI	Immunoassay method, troponin subunit	4,830	9.3%
JGS	Electrode, ion specific, sodium	1,457	2.8%
DHR	System, test, rheumatoid factor	510	1%
DHA	System, test, human chorionic gonadotropin	412	0.8%
CGA	Glucose oxidase, glucose	354	0.7%
LGD	Enzyme linked immunoabsorbent assay, toxoplasma gondii	225	0.4%
JLW	Radioimmunoassay, thyroid-stimulating hormone	221	0.4%
JHI	Visual, pregnancy hcg, prescription use	202	0.4%

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%13

Injury4.8%2,508

Malfunction91%47,287

Other3.5%1,798

Not given0.6%335

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

Questions about Beckman Coulter reports

How many FDA device reports name Beckman Coulter as manufacturer?

51,941 reports through August 2026, 656 of them in the latest 12 months.

Which of its brands appear most often?

Access 2 Immunoassay System (4,712), Unicel Dxi 800 Access Immunoassay System (3,125), UniCel DxC 600i SYNCHRON Access Clinical System (2,962), Coulter Lh 750 Hematology Analyzer (2,730) and Unicel Dxc 800 Synchron System (2,230).

Which device types does it report on?

analyzer, chemistry (photometric, discrete), for clinical use (46.5%), counter, differential cell (31.1%), immunoassay method, troponin subunit (9.3%) and electrode, ion specific, sodium (2.8%).

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.