Devices › Device types
FDA product code DHA · class 2 · Clinical Chemistry
System, test, human chorionic gonadotropin: medical device reports filed with FDA
3,587 reports carry this product code, 1993–2026; 30 brands with a page.
- 3,587
- reports with this product code
- 0% of all MAUDE reports
- 228
- reports, 12 months to August 2026
- 240 in the 12 months before
- 95.7%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code DHA is FDA's classification for "System, test, human chorionic gonadotropin" (clinical Chemistry panel), a class 2 device. 3,587 medical device reports carry this product code, 0% of the MAUDE database, from January 1993 to August 2026.
228 reports arrived in the 12 months to August 2026, close to the 240 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 (95.7%), injury (2.8%) and other (1.3%). 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 |
|---|---|---|
| A I D D Longford | 787 | 21.9% |
| Roche Diagnostics | 652 | 18.2% |
| Beckman Coulter | 412 | 11.5% |
| Abbott Ireland Diagnostics Division | 401 | 11.2% |
| Siemens Healthcare Diagnostics Products | 205 | 5.7% |
| Siemens Healthcare Diagnostics | 204 | 5.7% |
| Ortho-Clinical Diagnostics | 132 | 3.7% |
| Abbott Laboratories | 129 | 3.6% |
| Abbott Point Of Care | 122 | 3.4% |
| Abbott Manufacturing | 74 | 2.1% |
| Siemens Healthcare Diagnostics - Glasgow | 35 | 1% |
| Abbott Ireland | 2 | 0.1% |
| Abbott Diagnostics Division | 1 | 0% |
| Dade Behring | 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 |
|---|---|---|
| False positive result | 1,247 | 34.8% |
| High test results | 892 | 24.9% |
| Low test results | 660 | 18.4% |
| Incorrect or inadequate test results | 364 | 10.1% |
| False negative result | 287 | 8% |
| Non reproducible results | 214 | 6% |
| Incorrect, inadequate or imprecise result or readings | 108 | 3% |
| Incorrect measurementthe device measured wrongly | 34 | 0.9% |
| Imprecision | 8 | 0.2% |
| Output problem | 8 | 0.2% |
| Output, low | 8 | 0.2% |
| Device displays incorrect message | 7 | 0.2% |
| High readingsreadings were too high | 7 | 0.2% |
| Nonstandard device | 7 | 0.2% |
| Insufficient device problem information | 6 | 0.2% |
| Calibration problem | 5 | 0.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 0.1% |
| Low readingsreadings were too low | 5 | 0.1% |
| Material integrity problema problem with the device material | 4 | 0.1% |
| Calibration error | 3 | 0.1% |
Questions about system, test, human chorionic gonadotropin reports
What is product code DHA?
FDA's classification code for "System, test, human chorionic gonadotropin", class 2, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.
How many reports carry this code?
3,587 reports through August 2026, 228 of them in the latest 12 months.
Which brands appear most often?
ARCHITECT TOTAL B-hCG (689), Architect Total B-Hcg Reagent Kit (310), Alinity i Total B-hCG Reagent Kit (262), Unicel Dxi 800 Access Immunoassay System (138) and cobas 6000 e601 module (105). 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.