Device brand name · Ivd for hiv ag/ab
Alere Determine Hiv-1/2 Ag/Ab Combo: medical device reports filed with FDA
156 reports name it, 2015–2020. Manufacturer given most often on reports: Abbott Diagnostics Scarborough. Product code MZF.
- 156
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 89.7%
- classified as malfunction
- 93.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
156 medical device reports received by FDA name the brand "Alere Determine Hiv-1/2 Ag/Ab Combo" (ivd for hiv ag/ab); the manufacturer given most often on reports is Abbott Diagnostics Scarborough; received from June 2015 to June 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (89.7%) and injury (10.3%); across all test, hiv detection reports (product code MZF) death is recorded in 0.1% and malfunction in 93.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are false positive result (91.7%), false negative result (6.4%) and non reproducible results (5.1%). The patient problems coded most often are pregnancy, misdiagnosis and positive antinuclear antibodies (ana). 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
No report naming Alere Determine Hiv-1/2 Ag/Ab Combo was received in the five years to August 2026; the latest was received in June 2020.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,206 reports carrying product code MZF. 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 | 143 | 91.7% | 67.4% |
| False negative result | 10 | 6.4% | 15.3% |
| Non reproducible results | 8 | 5.1% | 4.4% |
| Incorrect, inadequate or imprecise result or readings | 7 | 4.5% | 5.8% |
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.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Pregnancypregnancy | 13 | 8.3% |
| Misdiagnosis | 10 | 6.4% |
| Positive antinuclear antibodies (ana) | 8 | 5.1% |
| Missing value reason | 3 | 1.9% |
| Cancer | 2 | 1.3% |
| Hiv, human immunodeficiency virus | 2 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Alere Determine Hiv-1/2 Ag/Ab Combo | Product code MZF | All MAUDE reports |
|---|---|---|---|
| Reports | 156 | 3,206 | 26,136,888 |
| Share of that pool | — | 4.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 10.3% | 3.8% | 36.2% |
| Classified as malfunction | 89.7% | 93.3% | 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 MZF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| DETERMINE HIV-1/2 Ag/Ab COMBO 25T | 801 | 569 | 0% |
| Alere Determine Hiv 1/2 Ag/Ab Combo | 500 | 0 | 0.2% |
| Elecsys HIV Duo | 319 | 300 | 0% |
| Elecsys HIV combi PT | 226 | 193 | 0% |
| ARCHITECT HIV Ag/Ab Combo | 214 | 4 | 0.5% |
| Prism Hiv O Plus | 170 | 0 | 0% |
| Architect Havab Igm Reagent | 335 | 0 | 0% |
| Advia Centaur Xp | 1,151 | 1 | 0% |
| Architect I2000sr Analyzer | 1,785 | 0 | 0.1% |
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 Alere Determine Hiv-1/2 Ag/Ab Combo reports
How many FDA reports name Alere Determine Hiv-1/2 Ag/Ab Combo?
156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (89.7%) and injury (10.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
false positive result (91.7%), false negative result (6.4%), non reproducible results (5.1%) and incorrect, inadequate or imprecise result or readings (4.5%). 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 Alere Determine Hiv-1/2 Ag/Ab Combo 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.