Devices › Nucleic-acid tests used for infectious disease screening of blood and plasma donations

Device brand name · Assay hyb and/or nucleic acid amp for detection of hcv rna hiv rna

cobas MPX - 480T: medical device reports filed with FDA

161 reports name it, 2025–2026. Manufacturer given most often on reports: Roche Molecular Systems - Branchburg. Product code QHO.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

161
device reports naming the brand: 0% of all MAUDE reports · about 161 a year; 158
reports, 12 months to August 2026: 3 in the 12 months before; 100%
classified as malfunction: 88.5% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

161 medical device reports received by FDA name the brand "cobas MPX - 480T" (assay hyb and/or nucleic acid amp for detection of hcv rna hiv rna); the manufacturer given most often on reports is Roche Molecular Systems - Branchburg; received from August 2025 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

158 reports arrived in the 12 months to August 2026, up 5167% 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 (100%); across all nucleic-acid tests used for infectious disease screening of blood and plasma donations reports (product code QHO) death is recorded in 0% and malfunction in 88.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are false positive result (44.1%), incorrect, inadequate or imprecise result or readings (29.2%) and non reproducible results (28%). 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.

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%161

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%161

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 485 reports carrying product code QHO. 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	71	44.1%	34.2%
Incorrect, inadequate or imprecise result or readings	47	29.2%	45.8%
Non reproducible results	45	28%	29.9%
False negative result	37	23%	30.9%
Output problem	32	19.9%	38.6%
Incorrect measurementthe device measured wrongly	2	1.2%	1%

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	cobas MPX - 480T	Product code QHO	All MAUDE reports
Reports	161	485	26,136,888
Share of that pool	—	33.2%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	0%	11.3%	36.2%
Classified as malfunction	100%	88.5%	62.3%
Filed by the manufacturer	100%	100%	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."

Questions about cobas MPX - 480T reports

How many FDA reports name cobas MPX - 480T?

161 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 158 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

false positive result (44.1%), incorrect, inadequate or imprecise result or readings (29.2%), non reproducible results (28%), false negative result (23%) and output problem (19.9%). 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 cobas MPX - 480T 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.