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FDA product code GKZ · class 2 · Hematology
Counter, differential cell: medical device reports filed with FDA
23,441 reports carry this product code, 1993–2026; 30 brands with a page.
- 23,441
- reports with this product code
- 0.1% of all MAUDE reports
- 63
- reports, 12 months to August 2026
- 85 in the 12 months before
- 95.7%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code GKZ is FDA's classification for "Counter, differential cell" (hematology panel), a class 2 device. 23,441 medical device reports carry this product code, 0.1% of the MAUDE database, from December 1993 to August 2026.
63 reports arrived in the 12 months to August 2026, down 26% from 85 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 (95.7%), other (2.7%) and injury (1.4%). 30 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
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 |
|---|---|---|
| Beckman Coulter | 16,128 | 68.8% |
| Abbott Diagnostics Division | 4,170 | 17.8% |
| Abbott Diagnostics Division/Celldyn | 1,612 | 6.9% |
| Becton Dickinson And Bd Biosciences | 408 | 1.7% |
| Abbott Laboratories | 311 | 1.3% |
| Siemens Healthcare Diagnostics | 128 | 0.5% |
| Becton Dickinson Caribe | 31 | 0.1% |
| Micro Typing Systems | 7 | 0% |
| Abbott Point Of Care | 4 | 0% |
| Bd Caribe | 3 | 0% |
| Bd | 1 | 0% |
| Becton Dickinson | 1 | 0% |
| Becton Dickinson And | 1 | 0% |
| Draeger Medical | 1 | 0% |
| Volcano | 1 | 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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Fluid/blood leak | 6,856 | 29.2% |
| Low test results | 3,877 | 16.5% |
| Leak/splashthe device leaked | 3,242 | 13.8% |
| Incorrect or inadequate test results | 2,084 | 8.9% |
| Incorrect, inadequate or imprecise result or readings | 2,010 | 8.6% |
| Nonstandard device | 1,798 | 7.7% |
| Device displays incorrect message | 1,433 | 6.1% |
| High test results | 1,232 | 5.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 722 | 3.1% |
| Contamination | 439 | 1.9% |
| High readingsreadings were too high | 364 | 1.6% |
| Other (for use when an appropriate device code cannot be identified) | 244 | 1% |
| Smoking | 239 | 1% |
| Breakthe device broke | 236 | 1% |
| Output problem | 229 | 1% |
| Device contamination with body fluid | 211 | 0.9% |
| Device alarm system | 190 | 0.8% |
| Device misassembled during manufacturing /shipping | 141 | 0.6% |
| Detachment of device component | 140 | 0.6% |
| Chemical spillage | 127 | 0.5% |
Questions about counter, differential cell reports
What is product code GKZ?
FDA's classification code for "Counter, differential cell", class 2, reviewed by the hematology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
23,441 reports through August 2026, 63 of them in the latest 12 months.
Which brands appear most often?
Coulter Lh 750 Hematology Analyzer (2,724), Cell-Dyn Emerald Cleaner (2,229), Coulter Lh 500 Hematology Analyzer (2,012), Coulter Lh 780 Hematology Analyzer (1,614) and Unicel Dxh 800 Coulter Cellular Analysis System (1,587). 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.