2026 data FDA MAUDE openFDA FDA Class I

Slide Stainer, Automated

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §864.3800 (Pathology panel).

FDA MAUDE casebook

openFDA event book Slide Stainer, Automated LIGHT-BOOK · MAUDE

#580 of 1000 · 1,446 reports · 2003–2026

  • BOOK 1,446 reports
  • RANK #580 of 1000
  • DEATH 1 death-typed
  • INJ 68 injury-typed
  • MALF 1,328 malfunction
  • SPAN 2003–2026
  • PEAK 2020: 436
  • PHOTO Fluid Jet Removal Sys…

Nearest event-volume peer: Fluid Jet Removal System (3 report gap)

Slide Stainer, Automated sits #580 of 1000 among tracked device types with 1,446 MAUDE reports spanning 2003–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Slide Stainer, Automated carries 91.8% MALFUNCTION-coded reports, 27.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 4.7% corpus 30.3% · below corpus mean (-25.6 pp)
  • MALF 91.8% corpus 64.8% · above corpus mean (+27.0 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 25% of coded problems · Lead manufacturer BECKMAN COULTER, INC. accounts for 100% of manufacturer-tagged reports · Top event location I is 55% of location-tagged rows .

Slide Stainer, Automated in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Slide Stainer, Automated carries 1,446 MAUDE reports, ranked #580 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,328 (91.8%)
Injury 68 (4.7%)
Other 44 (3.0%)
5 (0.3%)
Death 1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,005 (69.0%)
Other 407 (28.0%)
Required Intervention 25 (1.7%)
O 7 (0.5%)
Life Threatening 7 (0.5%)
R 2 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)
Hospitalization 1 (0.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 471
Mechanical Problem 330
Fluid/Blood Leak 289
Break 146
Structural Problem 130
Activation, Positioning or Separation Problem 87
Therapeutic or Diagnostic Output Failure 87
Leak/Splash 77
False Negative Result 41
Device Alarm System 23
Use of Device Problem 23
Adverse Event Without Identified Device or Use Problem 22
Appropriate Device Problem Term/Code Not Available 21
Overfill 20
Air/Gas in Device 19
Repair 18
Smoking 18
Fire 17
Incorrect Or Inadequate Test Results 13
Insufficient Device Problem Information 13

Yearly Trend

03
2003: 1
04
2004: 3
05
2005: 12
06
2006: 15
07
2007: 23
08
2008: 3
09
2009: 3
10
2010: 5
11
2011: 16
12
2012: 24
13
2013: 22
14
2014: 16
15
2015: 11
16
2016: 31
17
2017: 8
18
2018: 13
19
2019: 26
20
2020: 436
21
2021: 323
22
2022: 161
23
2023: 125
24
2024: 99
25
2025: 56
26
2026: 14

Reports fell to 56 in 2025, down from an average of 112 in the two years before.

Related Entities for Slide Stainer, Automated

Top Manufacturers

Event Locations

I 801 (55.4%)
630 (43.6%)
HOSPITAL 10 (0.7%)
NO INFORMATION 3 (0.2%)
OTHER 2 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Slide Stainer, Automated: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,446 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Slide Stainer, Automated are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Slide Stainer, Automated; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.