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FDA product code QJR · class N · Unknown
Reagents, 2019-novel coronavirus nucleic acid: medical device reports filed with FDA
20,139 reports carry this product code, 2020–2026; 25 brands with a page.
- 20,139
- reports with this product code
- 0.1% of all MAUDE reports
- 85
- reports, 12 months to August 2026
- 424 in the 12 months before
- 98.4%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code QJR is FDA's classification for "Reagents, 2019-novel coronavirus nucleic acid" (unknown panel), a class N device. 20,139 medical device reports carry this product code, 0.1% of the MAUDE database, from April 2020 to June 2026.
85 reports arrived in the 12 months to August 2026, down 80% from 424 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 (98.4%) and injury (1.5%). 25 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 |
|---|---|---|
| Abbott Diagnostics Scarborough | 6,233 | 30.9% |
| Roche Molecular Systems - Branchburg | 3,430 | 17% |
| Cue Health | 1,937 | 9.6% |
| Abbott Molecular | 1,807 | 9% |
| Lucira Health | 1,076 | 5.3% |
| Hologic | 889 | 4.4% |
| Quidel | 806 | 4% |
| Becton Dickinson & Sparks | 310 | 1.5% |
| Becton Dickinson | 147 | 0.7% |
| Lumiradx UK | 47 | 0.2% |
| Bd Rapis Diagnostics Suzhou | 5 | 0% |
| Quidel Ortho-Clinical Diagnostics | 2 | 0% |
| Becton Dickinson Caribe | 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 | 13,405 | 66.6% |
| Incorrect, inadequate or imprecise result or readings | 3,503 | 17.4% |
| False negative result | 2,809 | 13.9% |
| Output problem | 2,610 | 13% |
| Non reproducible results | 2,270 | 11.3% |
| Imprecise or erratic results | 580 | 2.9% |
| Nonstandard device | 109 | 0.5% |
| Unable to obtain readings | 103 | 0.5% |
| Off-label use | 67 | 0.3% |
| Device contaminated at the user facility | 51 | 0.3% |
| Improper or incorrect procedure or method | 37 | 0.2% |
| Increased sensitivity | 25 | 0.1% |
| Insufficient device problem information | 21 | 0.1% |
| Defective component | 14 | 0.1% |
| Low readingsreadings were too low | 13 | 0.1% |
| Incorrect measurementthe device measured wrongly | 12 | 0.1% |
| Device markings/labelling problema problem with the device markings or label | 10 | 0% |
| Application program problem | 9 | 0% |
| Product quality problem | 8 | 0% |
| Contamination | 7 | 0% |
Questions about reagents, 2019-novel coronavirus nucleic acid reports
What is product code QJR?
FDA's classification code for "Reagents, 2019-novel coronavirus nucleic acid", class N, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
20,139 reports through August 2026, 85 of them in the latest 12 months.
Which brands appear most often?
Id Now Covid-19 Assay (3,417), Cobas Sars-Cov-2 & Influenza A/B Test For Use On The Cobas Liat System (2,020), Cue Covid-19 Test For Home And Over The Counter Otc Use (1,823), Id Now Covid-19 (1,134) and Cobas Sars-Cov-2 Test (1,086). 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.