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FDA product code PPM · class 1 · Pathology
General purpose reagent: medical device reports filed with FDA
316 reports carry this product code, 2015–2026; 1 brands with a page.
- 316
- reports with this product code
- 0% of all MAUDE reports
- 230
- reports, 12 months to August 2026
- 8 in the 12 months before
- 95.6%
- classified as malfunction
- 62.3% across all reports
- 0.3%
- classified as death, as reported
- 0.9% across all reports
Product code PPM is FDA's classification for "General purpose reagent" (pathology panel), a class 1 device. 316 medical device reports carry this product code, 0% of the MAUDE database, from November 2015 to August 2026.
230 reports arrived in the 12 months to August 2026, up 2775% from 8 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 (95.6%), injury (3.5%) and death (0.3%). 1 brand name 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
| Brand | Reports | Latest 12 months | Classified as death | Classified as malfunction |
|---|---|---|---|---|
| Bd Bbl Mycoprep- Specimen Digestion/Decontamination Kit 75 Ml | 200 | 200 | 0% | 100% |
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 |
|---|---|---|
| Becton Dickinson & Sparks | 227 | 71.8% |
| Biomerieux | 26 | 8.2% |
| Becton Dickinson And Bd Biosciences | 6 | 1.9% |
| Abbott Molecular | 2 | 0.6% |
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 |
|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 218 | 69% |
| Contamination of device ingredient or reagent | 26 | 8.2% |
| Contamination | 21 | 6.6% |
| Low test results | 13 | 4.1% |
| Device markings/labelling problema problem with the device markings or label | 10 | 3.2% |
| Improper or incorrect procedure or method | 5 | 1.6% |
| Incorrect or inadequate test results | 5 | 1.6% |
| Labelling, instructions for use or training problem | 3 | 0.9% |
| Device damaged prior to receipt by user | 2 | 0.6% |
| Leak/splashthe device leaked | 2 | 0.6% |
| Missing information | 2 | 0.6% |
| Non reproducible results | 2 | 0.6% |
| Device contamination with chemical or other material | 1 | 0.3% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.3% |
| Device fell | 1 | 0.3% |
| Device handling problem | 1 | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.3% |
| Failure to analyze signal | 1 | 0.3% |
| False negative result | 1 | 0.3% |
| False positive result | 1 | 0.3% |
Questions about general purpose reagent reports
What is product code PPM?
FDA's classification code for "General purpose reagent", class 1, reviewed by the pathology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
316 reports through August 2026, 230 of them in the latest 12 months.
Which brands appear most often?
Bd Bbl Mycoprep- Specimen Digestion/Decontamination Kit 75 Ml (200). 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.