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2026 data FDA MAUDE openFDA FDA Class II

Flow Cytometric Reagents And Accessories.

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 II (moderate risk, special controls required), regulated under 21 CFR §864.5220 (Hematology panel).

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FDA MAUDE casebook

openFDA event book Flow Cytometric Reagents And Accessories. LIGHT-BOOK · MAUDE

#694 of 1000 · 896 reports · 2013–2026

  • BOOK 896 reports
  • RANK #694 of 1000
  • DEATH 0 death-typed
  • INJ 13 injury-typed
  • MALF 883 malfunction
  • SPAN 2013–2026
  • PEAK 2021: 251
  • PHOTO Probe

Nearest event-volume peer: Probe, Radiofrequency Lesion (1 report gap)

Flow Cytometric Reagents And Accessories. sits #694 of 1000 among tracked device types with 896 MAUDE reports spanning 2013–2026. 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

Flow Cytometric Reagents And Accessories. carries 98.5% MALFUNCTION-coded reports, 33.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.5% corpus 30.3% · below corpus mean (-28.8 pp)
  • MALF 98.5% corpus 64.8% · above corpus mean (+33.7 pp)

Lead product-problem code Fluid/Blood Leak is 40% of coded problems · Lead manufacturer BECKMAN COULTER accounts for 68% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Flow Cytometric Reagents And Accessories. in the event-volume neighbourhood

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

reports

What this shows Flow Cytometric Reagents And Accessories. carries 896 MAUDE reports, ranked #694 of 1000.

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

Event Types

Malfunction 883 (98.5%)
Injury 13 (1.5%)

Patient Outcomes

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

792 (88.8%)
Other 97 (10.9%)
Required Intervention 3 (0.3%)

Top Product Problems

Fluid/Blood Leak 357
Incorrect, Inadequate or Imprecise Result or Readings 293
Contamination 123
Leak/Splash 34
Device Operational Issue 30
Improper or Incorrect Procedure or Method 10
Device Operates Differently Than Expected 7
Device Markings/Labelling Problem 6
Break 5
Contamination of Device Ingredient or Reagent 5
Data Problem 4
Device Contamination with Chemical or Other Material 4
Mechanical Problem 4
Output Problem 4
Use of Device Problem 4
Adverse Event Without Identified Device or Use Problem 3
Computer Software Problem 3
Device Inoperable 3
Non Reproducible Results 2
Patient Data Problem 2

Yearly Trend

13
2013: 4
14
2014: 9
15
2015: 6
16
2016: 2
17
2017: 9
18
2018: 25
19
2019: 6
20
2020: 173
21
2021: 251
22
2022: 193
23
2023: 141
24
2024: 35
25
2025: 40
26
2026: 2

Reports fell to 40 in 2025, down from an average of 88 in the two years before.

Related Entities for Flow Cytometric Reagents And Accessories.

Top Manufacturers

BECKMAN COULTER 17
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5
BECKMAN COULTER, INC. 3

Event Locations

516 (57.6%)
I 380 (42.4%)

Compare BECKMAN COULTER vs BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. →

Nationwide devices with a comparable report-volume footprint

Flow Cytometric Reagents And Accessories. carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (896 here).

Probe, Radiofrequency Lesion 897 Laparoscopic Contraceptive Tubal Occlusion… 893 Unit, Cautery, Thermal, Ac-Powered 893 Vitrectomy, Instrument Cutter 899

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Flow Cytometric Reagents And Accessories. 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 Flow Cytometric Reagents And Accessories.; 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.