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FDA product code DHR · class 2 · Immunology
System, test, rheumatoid factor: medical device reports filed with FDA
518 reports carry this product code, 1994–2026; 2 brands with a page.
- 518
- reports with this product code
- 0% of all MAUDE reports
- 2
- reports, 12 months to August 2026
- 3 in the 12 months before
- 97.5%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code DHR is FDA's classification for "System, test, rheumatoid factor" (immunology panel), a class 2 device. 518 medical device reports carry this product code, 0% of the MAUDE database, from August 1994 to June 2026.
2 reports arrived in the 12 months to August 2026, down 33% from 3 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 (2.1%). 2 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
| Brand | Reports | Latest 12 months | Classified as death | Classified as malfunction |
|---|---|---|---|---|
| Unicel Dxc 800 Pro Synchron Chemistry Analyzer | 10 | 0 | 0% | 95.2% |
| Unicel Dxc 660i Synchron Access Clinical System | 1 | 0 | 0% | 96.9% |
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 | 510 | 98.5% |
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 |
|---|---|---|
| False positive result | 316 | 61% |
| High test results | 159 | 30.7% |
| Incorrect or inadequate test results | 26 | 5% |
| Nonstandard device | 8 | 1.5% |
| Low test results | 5 | 1% |
| Contamination of device ingredient or reagent | 4 | 0.8% |
| Device ingredient or reagent problem | 3 | 0.6% |
| Insufficient device problem information | 3 | 0.6% |
| Non reproducible results | 2 | 0.4% |
| Calibration problem | 1 | 0.2% |
| Device handling problem | 1 | 0.2% |
| Fluid/blood leak | 1 | 0.2% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.2% |
| Leak/splashthe device leaked | 1 | 0.2% |
| Output problem | 1 | 0.2% |
| Product quality problem | 1 | 0.2% |
| Unexpected therapeutic results | 1 | 0.2% |
Questions about system, test, rheumatoid factor reports
What is product code DHR?
FDA's classification code for "System, test, rheumatoid factor", class 2, reviewed by the immunology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
518 reports through August 2026, 2 of them in the latest 12 months.
Which brands appear most often?
Unicel Dxc 800 Pro Synchron Chemistry Analyzer (10) and Unicel Dxc 660i Synchron Access Clinical System (1). 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.