Devices › Counter, differential cell
Device brand name · Automated hematology analyzer
Cell-Dyn Ruby Analyzer: medical device reports filed with FDA
458 reports name it, 2008–2020. Manufacturer given most often on reports: Abbott Diagnostics Division. Product code GKZ.
- 458
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 96.9%
- classified as malfunction
- 95.7% across the product code
- 0.7%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 458 reports that name the brand "Cell-Dyn Ruby Analyzer" (automated hematology analyzer), received between January 2008 and September 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 (96.9%), injury (2.4%) and death (0.7%); 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 pressure problem (23.1%), device misassembled during manufacturing /shipping (15.1%) and low test results (12.4%). The patient problems coded most often are no patient involvement, death and needle stick/puncture. 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 Ruby Analyzer was received in the five years to August 2026; the latest was received in September 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
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 |
|---|---|---|---|
| Pressure problem | 106 | 23.1% | 0.5% |
| Device misassembled during manufacturing /shipping | 69 | 15.1% | 0.6% |
| Low test results | 57 | 12.4% | 16.5% |
| High test results | 51 | 11.1% | 5.3% |
| Smoking | 28 | 6.1% | 1% |
| Incorrect or inadequate test results | 21 | 4.6% | 8.9% |
| Breakthe device broke | 15 | 3.3% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 2.2% | 3.1% |
| Malfunction | 10 | 2.2% | 0.2% |
| Failure, intermittent | 9 | 2% | 0.1% |
| Fire | 9 | 2% | 0.2% |
| Charred | 8 | 1.7% | 0.1% |
| Incorrect, inadequate or imprecise result or readings | 8 | 1.7% | 8.6% |
| Nonstandard device | 8 | 1.7% | 7.7% |
| Device displays incorrect message | 7 | 1.5% | 6.1% |
| Fluid/blood leak | 6 | 1.3% | 29.2% |
| Installation-related problem | 5 | 1.1% | 0.1% |
| Other (for use when an appropriate device code cannot be identified) | 5 | 1.1% | 1% |
| Difficult or delayed positioning | 4 | 0.9% | 0% |
| Display difficult to read | 4 | 0.9% | 0.4% |
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 | 99 | 21.6% |
| Deaththe patient died; cause not stated by this term | 3 | 0.7% |
| Needle stick/puncture | 3 | 0.7% |
| Exposure to body fluids | 2 | 0.4% |
| Test result | 2 | 0.4% |
| Chemical exposure | 1 | 0.2% |
| Eye injury | 1 | 0.2% |
| Injurya physical injury | 1 | 0.2% |
| Misdiagnosis | 1 | 0.2% |
| Not applicable | 1 | 0.2% |
| Venipuncture | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cell-Dyn Ruby Analyzer | Product code GKZ | All MAUDE reports |
|---|---|---|---|
| Reports | 458 | 23,441 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 7 | 1 | 9 |
| Classified as injury | 2.4% | 1.4% | 36.2% |
| Classified as malfunction | 96.9% | 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 | Latest 12 months | Classified as death |
|---|---|---|---|
| Coulter Lh 750 Hematology Analyzer | 2,730 | 0 | 0% |
| Cell-Dyn Emerald Cleaner | 2,229 | 0 | 0% |
| Coulter Lh 500 Hematology Analyzer | 2,016 | 0 | 0% |
| Coulter Lh 780 Hematology Analyzer | 1,614 | 0 | 0% |
| Unicel Dxh 800 Coulter Cellular Analysis System | 1,591 | 0 | 0% |
| Fc 500 Flow Cytometer | 1,198 | 0 | 0% |
| Coulter Hmx Hematology Analyzer With Autoloader | 755 | 0 | 0% |
| Cell-Dyn Sapphire Analyzer | 636 | 0 | 0% |
| Coulter Act Diff 2 Analyzer | 536 | 0 | 0% |
| Cell-Dyn Wbc Reagent A | 519 | 0 | 0% |
| Coulter Act Diff Analyzer | 480 | 0 | 0% |
| Coulter Ac T Diff Analyzer | 449 | 0 | 0% |
| Coulter Ac T Diff 2 Analyzer | 425 | 0 | 0% |
| Cell-Dyn 1800 Analyzer | 377 | 0 | 0% |
| Coulter Lh750 Hematology Analyzer | 347 | 0 | 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 Ruby Analyzer reports
How many FDA reports name Cell-Dyn Ruby Analyzer?
458 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 (96.9%), injury (2.4%) and death (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pressure problem (23.1%), device misassembled during manufacturing /shipping (15.1%), low test results (12.4%), high test results (11.1%) and smoking (6.1%). 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 Ruby 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.