Device brand name · Counter differential cell

Coulter Lh 500 Hematology Analyzer: medical device reports filed with FDA

2,016 reports name it, 2005–2018. Manufacturer given most often on reports: Beckman Coulter. Product code GKZ.

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.

2,016
device reports naming the brand: 0% of all MAUDE reports · about 95 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 99%
classified as malfunction: 95.7% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 2,016 reports that name the brand "Coulter Lh 500 Hematology Analyzer" (counter differential cell), received between April 2005 and August 2018; the manufacturer given most often on reports is Beckman Coulter. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (99%), other (0.6%) and injury (0.3%); across all counter, differential cell reports (product code GKZ) death is recorded in 0.1% and malfunction in 95.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fluid/blood leak (50.4%), leak/splash (28.5%) and device displays incorrect message (9.9%). The patient problems coded most often are not applicable, test result and chemical exposure. 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."

Reports by month, five years

No report naming Coulter Lh 500 Hematology Analyzer was received in the five years to August 2026; the latest was received in August 2018.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0.3%6

Malfunction99%1,996

Other0.6%13

Not given0%1

Who filed the report

Manufacturer report100%2,016

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 23,441 reports carrying product code GKZ. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Fluid/blood leak	1,017	50.4%	29.2%
Leak/splashthe device leaked	574	28.5%	13.8%
Device displays incorrect message	200	9.9%	6.1%
Incorrect or inadequate test results	108	5.4%	8.9%
Device operates differently than expectedthe device behaved unexpectedly	67	3.3%	3.1%
High test results	54	2.7%	5.3%
Low test results	49	2.4%	16.5%
Output problem	26	1.3%	1%
Chemical spillage	24	1.2%	0.5%
Incorrect, inadequate or imprecise result or readings	24	1.2%	8.6%
Breakthe device broke	13	0.6%	1%
Device contamination with body fluid	11	0.5%	0.9%
Aspiration issue	10	0.5%	0.2%
Air leak	9	0.4%	0.2%
Ambient temperature problem	8	0.4%	0%
Hole in material	8	0.4%	0.4%
Thermal decomposition of device	8	0.4%	0.3%
Device alarm system	7	0.3%	0.8%
Kinkedthe tube or line kinked	6	0.3%	0.1%
Temperature problem	6	0.3%	0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Not applicable	262	13%
Test result	6	0.3%
Chemical exposure	5	0.2%
No patient involvement	3	0.1%
Diarrhea	1	0%
Electric shockan electric shock	1	0%
Exposure to body fluids	1	0%
Hemorrhage/blood loss/bleeding	1	0%
Nauseafeeling sick	1	0%
Painpain, site not specified	1	0%
Vomitingbeing sick	1	0%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Coulter Lh 500 Hematology Analyzer	Product code GKZ	All MAUDE reports
Reports	2,016	23,441	26,136,888
Share of that pool	—	8.6%	0%
Classified as death, per 1,000 reports	0	1	9
Classified as injury	0.3%	1.4%	36.2%
Classified as malfunction	99%	95.7%	62.3%
Filed by the manufacturer	100%	99.6%	94.9%

Shares are of reports, not 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."

Other brands with product code GKZ

Brand	Reports	Classified as death
Coulter Lh 750 Hematology Analyzer	2,730	0%
Cell-Dyn Emerald Cleaner	2,229	0%
Coulter Lh 780 Hematology Analyzer	1,614	0%
Unicel Dxh 800 Coulter Cellular Analysis System	1,591	0%
Fc 500 Flow Cytometer	1,198	0%
Coulter Hmx Hematology Analyzer With Autoloader	755	0%
Cell-Dyn Sapphire Analyzer	636	0%
Coulter Act Diff 2 Analyzer	536	0%
Cell-Dyn Wbc Reagent A	519	0%
Coulter Act Diff Analyzer	480	0%
Cell-Dyn Ruby Analyzer	458	0.7%
Coulter Ac T Diff Analyzer	449	0%
Coulter Ac T Diff 2 Analyzer	425	0%
Cell-Dyn 1800 Analyzer	377	0%
Coulter Lh750 Hematology Analyzer	347	0%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Coulter Lh 500 Hematology Analyzer reports

How many FDA reports name Coulter Lh 500 Hematology Analyzer?

2,016 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (99%), other (0.6%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fluid/blood leak (50.4%), leak/splash (28.5%), device displays incorrect message (9.9%), incorrect or inadequate test results (5.4%) and device operates differently than expected (3.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Coulter Lh 500 Hematology Analyzer was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.