Devices › Slide stainer, automated
Device brand name · Automated slide stainer
Autostainer Link 48: medical device reports filed with FDA
711 reports name it, 2013–2023. Manufacturer given most often on reports: Agilent Technologies Singapore Intl Pte. Product code KPA.
- 711
- device reports naming the brand
- 0% of all MAUDE reports · about 57 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 100%
- classified as malfunction
- 91.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
711 medical device reports received by FDA name the brand "Autostainer Link 48" (automated slide stainer); the manufacturer given most often on reports is Agilent Technologies Singapore Intl Pte; received from December 2013 to June 2023. 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 (100%); across all slide stainer, automated reports (product code KPA) death is recorded in 0.1% and malfunction in 91.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect, inadequate or imprecise result or readings (48.2%), mechanical problem (37.8%) and fluid/blood leak (25.9%). 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.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,447 reports carrying product code KPA. 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 |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 343 | 48.2% | 32.5% |
| Mechanical problema mechanical problem | 269 | 37.8% | 22.8% |
| Fluid/blood leak | 184 | 25.9% | 19.9% |
| Activation, positioning or separation problem | 58 | 8.2% | 6% |
| Therapeutic or diagnostic output failure | 58 | 8.2% | 5.9% |
| Leak/splashthe device leaked | 43 | 6% | 5.3% |
| False negative result | 20 | 2.8% | 2.8% |
| Air/gas in device | 19 | 2.7% | 1.2% |
| Gas/air leak | 8 | 1.1% | 0.6% |
| Device stops intermittentlythe device stopped now and then | 7 | 1% | 0.5% |
| Defective devicethe device was defective | 5 | 0.7% | 0.6% |
| Failure to deliverthe device did not deliver the dose or item | 5 | 0.7% | 0.5% |
| Breakthe device broke | 4 | 0.6% | 10.1% |
| Loose or intermittent connection | 4 | 0.6% | 0.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 0.4% | 0.4% |
| Device sensing problem | 3 | 0.4% | 0.3% |
| Material discolored | 3 | 0.4% | 0.3% |
| Output problem | 2 | 0.3% | 0.7% |
| Programming issue | 2 | 0.3% | 0.1% |
| Failure to infuse | 1 | 0.1% | 0.1% |
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 | Autostainer Link 48 | Product code KPA | All MAUDE reports |
|---|---|---|---|
| Reports | 711 | 1,447 | 26,136,888 |
| Share of that pool | — | 49.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 0% | 4.8% | 36.2% |
| Classified as malfunction | 100% | 91.8% | 62.3% |
| Filed by the manufacturer | 98.6% | 97.9% | 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 KPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Symphony | 1,163 | 133 | 1.6% |
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 Autostainer Link 48 reports
How many FDA reports name Autostainer Link 48?
711 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (48.2%), mechanical problem (37.8%), fluid/blood leak (25.9%), activation, positioning or separation problem (8.2%) and therapeutic or diagnostic output failure (8.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.6%) and voluntary reports (1.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Autostainer Link 48 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.