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2026 data FDA MAUDE openFDA FDA Class I

Single (Specified) Analyte Controls (Assayed And Unassayed)

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 §862.1660 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Single Analyte Controls LIGHT-BOOK · MAUDE

#791 of 1000 · 672 reports · 1994–2026

  • BOOK 672 reports
  • RANK #791 of 1000
  • DEATH 0 death-typed
  • INJ 36 injury-typed
  • MALF 624 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 82
  • PHOTO Camera

Nearest event-volume peer: Camera, Surgical And Accessories (0 report gap)

Single (Specified) Analyte Controls (Assayed And Unassayed) sits #791 of 1000 among tracked device types with 672 MAUDE reports spanning 1994–2026. 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

Single Analyte Controls carries 92.9% MALFUNCTION-coded reports, 28.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.4% corpus 30.3% · below corpus mean (-24.9 pp)
  • MALF 92.9% corpus 64.8% · above corpus mean (+28.0 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 48% of coded problems · Lead manufacturer BAYER HEALTHCARE LLC accounts for 47% of manufacturer-tagged reports · Top event location I is 56% of location-tagged rows .

Single Analyte Controls in the event-volume neighbourhood

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

reports

What this shows Single (Specified) Analyte Controls (Assayed And Unassayed) carries 672 MAUDE reports, ranked #791 of 1000.

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

Event Types

Malfunction 624 (92.9%)
Injury 36 (5.4%)
Other 7 (1.0%)
5 (0.7%)

Patient Outcomes

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

651 (96.6%)
Other 14 (2.1%)
Hospitalization 3 (0.4%)
Required Intervention 3 (0.4%)
H 1 (0.1%)
S 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 335
Device Operates Differently Than Expected 67
High Test Results 67
Incorrect Or Inadequate Test Results 48
Display or Visual Feedback Problem 46
Improper or Incorrect Procedure or Method 21
Fluid/Blood Leak 15
Break 10
Leak/Splash 9
Low Test Results 9
Use of Incorrect Control/Treatment Settings 9
Material Frayed 8
Nonstandard Device 8
Missing Information 7
Smoking 7
Adverse Event Without Identified Device or Use Problem 6
Appropriate Device Problem Term/Code Not Available 6
High Readings 6
Output Problem 6
Calibration Problem 5

Yearly Trend

94
1994: 1
02
2002: 1
07
2007: 2
09
2009: 1
10
2010: 6
11
2011: 62
12
2012: 32
13
2013: 51
14
2014: 48
15
2015: 67
16
2016: 37
17
2017: 19
18
2018: 35
19
2019: 82
20
2020: 77
21
2021: 43
22
2022: 24
23
2023: 22
24
2024: 30
25
2025: 22
26
2026: 10

Reports in 2025 (22) held close to the prior two-year average of 26.

Related Entities for Single (Specified) Analyte Controls (Assayed And Unassayed)

Top Manufacturers

BAYER HEALTHCARE LLC 43
BECKMAN COULTER, INC. 14
BECKMAN COULTER INC. 13
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 13
TRIVIDIA HEALTH INC 8

Event Locations

I 376 (56.0%)
250 (37.2%)
OTHER 33 (4.9%)
HOSPITAL 5 (0.7%)
NO INFORMATION 3 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.3%)
HOME 1 (0.1%)
INVALID DATA 1 (0.1%)
LABORATORY 1 (0.1%)

Compare BAYER HEALTHCARE LLC vs BECKMAN COULTER, INC. →

Nationwide devices with a comparable report-volume footprint

Single Analyte Controls 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 (672 here).

Camera, Surgical And Accessories 672 Forceps, General & Plastic Surgery 673 Hearing Aid, Air-Conduction, Prescription 673 Hearing Aid 673

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 Single Analyte Controls 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 Single Analyte Controls; 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.