PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Azo Dye, Calcium

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 §862.1145 (Clinical Chemistry panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Azo Dye, Calcium LIGHT-BOOK · MAUDE

#990 of 1000 · 372 reports · 1997–2026

  • BOOK 372 reports
  • RANK #990 of 1000
  • DEATH 0 death-typed
  • INJ 4 injury-typed
  • MALF 367 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 60
  • PHOTO Lens, Contact,

Nearest event-volume peer: Lens, Contact, (Disposable) (0 report gap)

Azo Dye, Calcium sits #990 of 1000 among tracked device types with 372 MAUDE reports spanning 1997–2026. 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

Azo Dye, Calcium carries 98.7% MALFUNCTION-coded reports, 33.8pp 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 1.1% corpus 30.3% · below corpus mean (-29.2 pp)
  • MALF 98.7% corpus 64.8% · above corpus mean (+33.8 pp)

Lead product-problem code High Test Results is 53% of coded problems · Lead manufacturer ABBOTT GMBH accounts for 46% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Azo Dye, Calcium in the event-volume neighbourhood

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

reports

What this shows Azo Dye, Calcium carries 372 MAUDE reports, ranked #990 of 1000.

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

Event Types

Malfunction 367 (98.7%)
Injury 4 (1.1%)
Other 1 (0.3%)

Patient Outcomes

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

368 (99.2%)
R 1 (0.3%)
Hospitalization 1 (0.3%)
Required Intervention 1 (0.3%)

Top Product Problems

High Test Results 200
Low Test Results 126
Incorrect Or Inadequate Test Results 16
Incorrect, Inadequate or Imprecise Result or Readings 12
Packaging Problem 4
Adverse Event Without Identified Device or Use Problem 3
False Negative Result 3
High Readings 2
Imprecise or Erratic Results 2
Device Operates Differently Than Expected 1
Device Rinsing Issue 1
Failure to Align 1
False Positive Result 1
Fluid/Blood Leak 1
Low Readings 1
Output, high 1
Probe failure 1
Unexpected Therapeutic Results 1

Yearly Trend

97
1997: 1
07
2007: 3
08
2008: 4
09
2009: 8
10
2010: 10
11
2011: 9
12
2012: 5
13
2013: 8
14
2014: 5
15
2015: 4
16
2016: 3
17
2017: 26
18
2018: 21
19
2019: 29
20
2020: 33
21
2021: 24
22
2022: 17
23
2023: 29
24
2024: 34
25
2025: 60
26
2026: 39

Reports rose to 60 in 2025, up from an average of 32 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Azo Dye, Calcium

Top Manufacturers

ABBOTT GMBH 137
ABBOTT MANUFACTURING INC 74
ORTHO-CLINICAL DIAGNOSTICS 27
ROCHE DIAGNOSTICS 20
SIEMENS HEALTHCARE DIAGNOSTICS INC. 16
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 16
ABBOTT LABORATORIES 8

Event Locations

219 (58.9%)
I 133 (35.8%)
LABORATORY 12 (3.2%)
OTHER 8 (2.2%)

Compare ABBOTT GMBH vs ABBOTT MANUFACTURING INC →

Nationwide devices with a comparable report-volume footprint

Azo Dye, Calcium 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 (372 here).

Lens, Contact, 372 Crutch 373 Multi-Analyte Test System With Algorithmic… 371 Probe, Thermodilution 373

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 Azo Dye, Calcium 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 Azo Dye, Calcium; 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.