Devices › Device types
FDA product code JLW · class 2 · Clinical Chemistry
Radioimmunoassay, thyroid-stimulating hormone: medical device reports filed with FDA
2,774 reports carry this product code, 1994–2026; 26 brands with a page.
- 2,774
- reports with this product code
- 0% of all MAUDE reports
- 91
- reports, 12 months to August 2026
- 125 in the 12 months before
- 97%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code JLW is FDA's classification for "Radioimmunoassay, thyroid-stimulating hormone" (clinical Chemistry panel), a class 2 device. 2,774 medical device reports carry this product code, 0% of the MAUDE database, from March 1994 to August 2026.
91 reports arrived in the 12 months to August 2026, down 27% from 125 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 (97%), injury (2.6%) and other (0.4%). 26 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 |
|---|---|---|
| Roche Diagnostics | 956 | 34.5% |
| Ortho-Clinical Diagnostics | 705 | 25.4% |
| A I D D Longford | 264 | 9.5% |
| Beckman Coulter | 221 | 8% |
| Abbott Ireland Diagnostics Division | 161 | 5.8% |
| Siemens Healthcare Diagnostics | 66 | 2.4% |
| Siemens Healthcare Diagnostics - Glasgow | 55 | 2% |
| Abbott Manufacturing | 20 | 0.7% |
| Abbott Laboratories | 17 | 0.6% |
| Biom Rieux | 7 | 0.3% |
| Ortho Clinical Diagnostics | 3 | 0.1% |
| Tosoh | 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 |
|---|---|---|
| Low test results | 1,177 | 42.4% |
| High test results | 988 | 35.6% |
| Incorrect or inadequate test results | 365 | 13.2% |
| Incorrect, inadequate or imprecise result or readings | 131 | 4.7% |
| Non reproducible results | 94 | 3.4% |
| False positive result | 24 | 0.9% |
| High readingsreadings were too high | 17 | 0.6% |
| Nonstandard device | 16 | 0.6% |
| False negative result | 14 | 0.5% |
| Device damaged prior to usethe device was damaged before use | 11 | 0.4% |
| Low readingsreadings were too low | 11 | 0.4% |
| Unable to obtain readings | 11 | 0.4% |
| Detachment of device component | 9 | 0.3% |
| Incorrect measurementthe device measured wrongly | 9 | 0.3% |
| Insufficient device problem information | 8 | 0.3% |
| False reading from device non-compliance | 7 | 0.3% |
| Chemical problem | 6 | 0.2% |
| Component falling | 6 | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 0.1% |
| Output problem | 4 | 0.1% |
Questions about radioimmunoassay, thyroid-stimulating hormone reports
What is product code JLW?
FDA's classification code for "Radioimmunoassay, thyroid-stimulating hormone", 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?
2,774 reports through August 2026, 91 of them in the latest 12 months.
Which brands appear most often?
Vitros Immunodiagnostic Products Tsh Reagent Pack (537), Elecsys Tsh Assay (529), Tsh Thyrotropin (214), Architect Tsh (196) and Elecsys Tsh (157). 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.