2026 data FDA MAUDE openFDA FDA Class I

Device, Microtiter Diluting/Dispensing

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 §866.2500 (Microbiology panel).

FDA MAUDE casebook

openFDA event book Device, Microtiter Diluting/Dispensing LIGHT-BOOK · MAUDE

#253 of 1000 · 7,712 reports · 1996–2026

  • BOOK 7,712 reports
  • RANK #253 of 1000
  • DEATH 0 death-typed
  • INJ 23 injury-typed
  • MALF 5,474 malfunction
  • SPAN 1996–2026
  • PEAK 2007: 1,118
  • PHOTO Nasopharyngoscope

Nearest event-volume peer: Nasopharyngoscope (Flexible Or Rigid) (21 report gap)

Device, Microtiter Diluting/Dispensing sits #253 of 1000 among tracked device types with 7,712 MAUDE reports spanning 1996–2026. 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 →

Injury-coded reports sit below the device-type norm

Device, Microtiter Diluting/Dispensing carries 0.3% INJURY-coded reports, 30.0pp below 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 0.3% corpus 30.3% · below corpus mean (-30.0 pp)
  • MALF 71.0% corpus 64.8% · above corpus mean (+6.2 pp)

Lead product-problem code Pipette, failure to aspirate is 30% of coded problems · Lead manufacturer HAMILTON BONADUZ AG accounts for 87% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Device, Microtiter Diluting/Dispensing in the event-volume neighbourhood

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

reports

What this shows Device, Microtiter Diluting/Dispensing carries 7,712 MAUDE reports, ranked #253 of 1000.

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

Event Types

Malfunction 5,474 (71.0%)
Other 2,201 (28.5%)
Injury 23 (0.3%)
14 (0.2%)

Patient Outcomes

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

4,862 (63.0%)
Other 2,842 (36.8%)
Required Intervention 7 (0.1%)
S 3 (0.0%)

Top Product Problems

Pipette, failure to aspirate 4,235
Alarm, failure of warning 3,671
Error or warning message, failure to produce 1,716
Inaccurate Delivery 1,025
Device Alarm System 662
Display Difficult to Read 612
Other (for use when an appropriate device code cannot be identified) 364
Aspiration Issue 348
Failure to Deliver 277
False Reading From Device Non-Compliance 214
Repair 163
Replace 151
Aspiration, incomplete 142
Failure to Obtain Sample 102
Nonstandard Device 98
Use of Device Problem 95
Bubble(s) 78
Filling Problem 78
Device Issue 76
Patient Data Problem 59

Yearly Trend

96
1996: 36
97
1997: 142
98
1998: 345
99
1999: 393
00
2000: 421
01
2001: 267
02
2002: 340
03
2003: 579
04
2004: 593
05
2005: 855
06
2006: 897
07
2007: 1,118
08
2008: 919
09
2009: 388
10
2010: 190
11
2011: 47
12
2012: 1
13
2013: 1
14
2014: 2
15
2015: 1
19
2019: 102
20
2020: 2
21
2021: 8
22
2022: 26
23
2023: 15
24
2024: 10
25
2025: 8
26
2026: 6

Reports fell to 8 in 2025, down from an average of 13 in the two years before.

Related Entities for Device, Microtiter Diluting/Dispensing

Event Locations

3,899 (50.6%)
INVALID DATA 2,305 (29.9%)
OTHER 1,293 (16.8%)
I 107 (1.4%)
HOSPITAL 98 (1.3%)
NOT APPLICABLE 7 (0.1%)
LABORATORY 2 (0.0%)
UNKNOWN 1 (0.0%)

Compare HAMILTON BONADUZ AG vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with a comparable report-volume footprint

Device, Microtiter Diluting/Dispensing 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 (7,712 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Device, Microtiter Diluting/Dispensing 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 Device, Microtiter Diluting/Dispensing; 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.