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2026 data FDA MAUDE openFDA FDA Class II

Diazo Colorimetry, Bilirubin

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 §862.1110 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Diazo Colorimetry, Bilirubin LIGHT-BOOK · MAUDE

#971 of 1000 · 399 reports · 1999–2026

  • BOOK 399 reports
  • RANK #971 of 1000
  • DEATH 0 death-typed
  • INJ 4 injury-typed
  • MALF 391 malfunction
  • SPAN 1999–2026
  • PEAK 2025: 52
  • PHOTO Bag

Nearest event-volume peer: Bag, Urine Collection, Leg, For External Use, Sterile (0 report gap)

Diazo Colorimetry, Bilirubin sits #971 of 1000 among tracked device types with 399 MAUDE reports spanning 1999–2026. 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

Diazo Colorimetry, Bilirubin carries 98.0% MALFUNCTION-coded reports, 33.2pp 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 1.0% corpus 30.3% · below corpus mean (-29.3 pp)
  • MALF 98.0% corpus 64.8% · above corpus mean (+33.2 pp)

Lead product-problem code High Test Results is 37% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 33% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Diazo Colorimetry, Bilirubin in the event-volume neighbourhood

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

reports

What this shows Diazo Colorimetry, Bilirubin carries 399 MAUDE reports, ranked #971 of 1000.

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

Event Types

Malfunction 391 (98.0%)
Injury 4 (1.0%)
Other 4 (1.0%)

Patient Outcomes

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

381 (96.0%)
Other 9 (2.3%)
Congenital Anomaly 3 (0.8%)
O 1 (0.3%)
Death 1 (0.3%)
Life Threatening 1 (0.3%)
Required Intervention 1 (0.3%)

Top Product Problems

High Test Results 160
Low Test Results 140
Non Reproducible Results 37
Incorrect Or Inadequate Test Results 20
Incorrect, Inadequate or Imprecise Result or Readings 18
Break 7
Crack 7
Leak/Splash 7
Nonstandard Device 7
Fluid/Blood Leak 5
Unable to Obtain Readings 5
High Readings 4
Output Problem 4
Insufficient Device Problem Information 3
Device Damaged Prior to Receipt by User 2
Device Packaging Compromised 2
False Positive Result 2
Patient-Device Incompatibility 2
Replace 2
Signal Artifact/Noise 2

Yearly Trend

99
1999: 1
00
2000: 1
01
2001: 1
02
2002: 1
05
2005: 1
06
2006: 1
07
2007: 2
08
2008: 8
09
2009: 3
10
2010: 6
11
2011: 38
12
2012: 14
13
2013: 8
14
2014: 3
15
2015: 7
16
2016: 4
17
2017: 11
18
2018: 23
19
2019: 25
20
2020: 31
21
2021: 22
22
2022: 26
23
2023: 34
24
2024: 39
25
2025: 52
26
2026: 37

Reports rose to 52 in 2025, up from an average of 37 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Diazo Colorimetry, Bilirubin

Top Manufacturers

ROCHE DIAGNOSTICS 110
ABBOTT GMBH 97
ABBOTT MANUFACTURING INC 45
ABBOTT LABORATORIES 26
BECKMAN COULTER, INC. 22
ORTHO-CLINICAL DIAGNOSTICS 13
ABBOTT MANUFACTURING, INC. 11
SIEMENS HEALTHCARE DIAGNOSTICS INC. 10

Event Locations

260 (65.2%)
I 116 (29.1%)
LABORATORY 15 (3.8%)
NO INFORMATION 3 (0.8%)
NOT APPLICABLE 3 (0.8%)
HOSPITAL 1 (0.3%)
OTHER 1 (0.3%)

Compare ROCHE DIAGNOSTICS vs ABBOTT GMBH →

Nationwide devices with a comparable report-volume footprint

Diazo Colorimetry, Bilirubin 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 (399 here).

Bag 399 Device, Percutaneous Retrieval 398 Probe, Blood-Flow, Extravascular 398 Device, Medical Examination, Ac Powered 401

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 Diazo Colorimetry, Bilirubin 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 Diazo Colorimetry, Bilirubin; 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.