Device brand name · Automated hematology analyzer

Cell-Dyn Sapphire Analyzer: medical device reports filed with FDA

636 reports name it, 2007–2020. Manufacturer given most often on reports: Abbott Diagnostics Division. 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.

636
device reports naming the brand: 0% of all MAUDE reports · about 33 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 97.5%
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 636 reports that name the brand "Cell-Dyn Sapphire Analyzer" (automated hematology analyzer), received between July 2007 and July 2020; the manufacturer given most often on reports is Abbott Diagnostics Division. 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 (97.5%) and injury (2.5%); 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 device displays incorrect message (30.2%), high test results (18.6%) and syringe, defective (14.8%). The patient problems coded most often are no patient involvement, eye injury and test result. 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 Cell-Dyn Sapphire Analyzer was received in the five years to August 2026; the latest was received in July 2020.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury2.5%16

Malfunction97.5%620

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%636

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
Device displays incorrect message	192	30.2%	6.1%
High test results	118	18.6%	5.3%
Syringe, defective	94	14.8%	0.5%
Low test results	89	14%	16.5%
Incorrect or inadequate test results	51	8%	8.9%
Breakthe device broke	26	4.1%	1%
Device operates differently than expectedthe device behaved unexpectedly	25	3.9%	3.1%
Device sensing problem	21	3.3%	0.2%
Naturally worn	19	3%	0.2%
Smoking	19	3%	1%
Fluid/blood leak	16	2.5%	29.2%
Mechanical problema mechanical problem	13	2%	0.3%
Display difficult to read	9	1.4%	0.4%
Leak/splashthe device leaked	8	1.3%	13.8%
Malfunction	8	1.3%	0.2%
Aspiration issue	7	1.1%	0.2%
Display or visual feedback problem	7	1.1%	0.1%
Contamination	4	0.6%	1.9%
Device inoperablethe device could not be used	4	0.6%	0.2%
Failure to sense	4	0.6%	0.1%

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
No patient involvement	21	3.3%
Eye injury	5	0.8%
Test result	5	0.8%
Chemical exposure	4	0.6%
Injurya physical injury	2	0.3%
Burning sensationa burning feeling	1	0.2%
Exposure to body fluids	1	0.2%
Hemorrhage/blood loss/bleeding	1	0.2%
Laceration(s)	1	0.2%
Misdiagnosis	1	0.2%
Needle stick/puncture	1	0.2%
Skin irritationirritated skin	1	0.2%
Surgical procedure, unnecessary	1	0.2%
Therapy/non-surgical treatment, unncessary	1	0.2%
Transfusion of blood products	1	0.2%

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

In context

Measure	Cell-Dyn Sapphire Analyzer	Product code GKZ	All MAUDE reports
Reports	636	23,441	26,136,888
Share of that pool	—	2.7%	0%
Classified as death, per 1,000 reports	0	1	9
Classified as injury	2.5%	1.4%	36.2%
Classified as malfunction	97.5%	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 500 Hematology Analyzer	2,016	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%
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 Cell-Dyn Sapphire Analyzer reports

How many FDA reports name Cell-Dyn Sapphire Analyzer?

636 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 (97.5%) and injury (2.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device displays incorrect message (30.2%), high test results (18.6%), syringe, defective (14.8%), low test results (14%) and incorrect or inadequate test results (8%). 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 Cell-Dyn Sapphire 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.