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FDA product code DHX · class 2 · Immunology
System, test, carcinoembryonic antigen: medical device reports filed with FDA
310 reports carry this product code, 1996–2026; 3 brands with a page.
- 310
- reports with this product code
- 0% of all MAUDE reports
- 19
- reports, 12 months to August 2026
- 18 in the 12 months before
- 95.5%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code DHX is FDA's classification for "System, test, carcinoembryonic antigen" (immunology panel), a class 2 device. 310 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.
19 reports arrived in the 12 months to August 2026, close to the 18 of 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 (95.5%), other (2.3%) and injury (1.9%). 3 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 |
|---|---|---|---|---|
| Architect I2000 Analyzer | 8 | 0 | 0% | 91.5% |
| Architect I2000sr Analyzer | 5 | 0 | 0.1% | 95.2% |
| Architect Reaction Vessel | 2 | 0 | 0% | 100% |
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 |
|---|---|---|
| Abbott Ireland | 45 | 14.5% |
| Beckman Coulter | 19 | 6.1% |
| Abbott Manufacturing | 10 | 3.2% |
| Siemens Healthcare Diagnostics Products | 9 | 2.9% |
| Abbott Ireland Diagnostics Division | 4 | 1.3% |
| Abbott Laboratories | 1 | 0.3% |
| Tosoh | 1 | 0.3% |
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 |
|---|---|---|
| High test results | 105 | 33.9% |
| Low test results | 99 | 31.9% |
| Incorrect or inadequate test results | 30 | 9.7% |
| Non reproducible results | 24 | 7.7% |
| Incorrect, inadequate or imprecise result or readings | 18 | 5.8% |
| False negative result | 12 | 3.9% |
| Low readingsreadings were too low | 7 | 2.3% |
| Nonstandard device | 4 | 1.3% |
| Incorrect measurementthe device measured wrongly | 3 | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.6% |
| False reading from device non-compliance | 2 | 0.6% |
| Calibration problem | 1 | 0.3% |
| Device displays incorrect message | 1 | 0.3% |
| False positive result | 1 | 0.3% |
| High readingsreadings were too high | 1 | 0.3% |
| Leak/splashthe device leaked | 1 | 0.3% |
| Mechanical problema mechanical problem | 1 | 0.3% |
| Other (for use when an appropriate device code cannot be identified) | 1 | 0.3% |
| Output below specifications | 1 | 0.3% |
| Particulates | 1 | 0.3% |
Questions about system, test, carcinoembryonic antigen reports
What is product code DHX?
FDA's classification code for "System, test, carcinoembryonic antigen", class 2, reviewed by the immunology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
310 reports through August 2026, 19 of them in the latest 12 months.
Which brands appear most often?
Architect I2000 Analyzer (8), Architect I2000sr Analyzer (5) and Architect Reaction Vessel (2). 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.