Devices › System, test, human chorionic gonadotropin
Device brand name · System test human chorionic gonadotropin
Alinity i Total B-hCG Reagent Kit: medical device reports filed with FDA
262 reports name it, 2020–2026. Manufacturer given most often on reports: Abbott Ireland Diagnostics Division. Product code DHA.
- 262
- device reports naming the brand
- 0% of all MAUDE reports · about 41 a year
- 74
- reports, 12 months to August 2026
- 52 in the 12 months before
- 98.1%
- classified as malfunction
- 95.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
262 medical device reports received by FDA name the brand "Alinity i Total B-hCG Reagent Kit" (system test human chorionic gonadotropin); the manufacturer given most often on reports is Abbott Ireland Diagnostics Division; received from February 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
74 reports arrived in the 12 months to August 2026, up 42% from 52 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 (98.1%) and injury (1.9%); across all system, test, human chorionic gonadotropin reports (product code DHA) death is recorded in 0% 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 false positive result (86.6%), false negative result (10.3%) and high test results (1.5%). 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,587 reports carrying product code DHA. 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 |
|---|---|---|---|
| False positive result | 227 | 86.6% | 34.8% |
| False negative result | 27 | 10.3% | 8% |
| High test results | 4 | 1.5% | 24.9% |
| Incorrect, inadequate or imprecise result or readings | 2 | 0.8% | 3% |
| Low test results | 1 | 0.4% | 18.4% |
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.
In context
| Measure | Alinity i Total B-hCG Reagent Kit | Product code DHA | All MAUDE reports |
|---|---|---|---|
| Reports | 262 | 3,587 | 26,136,888 |
| Share of that pool | — | 7.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 1.9% | 2.8% | 36.2% |
| Classified as malfunction | 98.1% | 95.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.4% | 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 DHA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| ARCHITECT TOTAL B-hCG | 689 | 51 | 0% |
| Architect Total B-Hcg Reagent Kit | 310 | 0 | 0% |
| Unicel Dxi 800 Access Immunoassay System | 3,133 | 0 | 0% |
| cobas 6000 e601 module | 902 | 85 | 0% |
| Access 2 Immunoassay System | 4,719 | 0 | 0% |
| Analytical E Module | 772 | 0 | 0% |
| Elecsys 2010 Rack | 657 | 0 | 0% |
| Cobas E411 Rack System | 367 | 0 | 0.3% |
| Dimension Clinical Chemistry System | 1,895 | 0 | 0.2% |
| Cobas E411 Disk System | 285 | 0 | 0% |
| Architect I2000sr Analyzer | 1,785 | 0 | 0.1% |
| Architect I2000 Analyzer | 386 | 0 | 0% |
| Elecsys 2010 Disk | 260 | 0 | 0% |
| Architect I1000sr Analyzer | 310 | 0 | 0.3% |
| Immulite 2000 | 446 | 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 Alinity i Total B-hCG Reagent Kit reports
How many FDA reports name Alinity i Total B-hCG Reagent Kit?
262 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 74 in the latest 12 months.
What kinds of events are reported?
malfunction (98.1%) and injury (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
false positive result (86.6%), false negative result (10.3%), high test results (1.5%), incorrect, inadequate or imprecise result or readings (0.8%) and low test results (0.4%). 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 Alinity i Total B-hCG Reagent Kit 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.