Calibrator, Multi-Analyte Mixture
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 §862.1150 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book Calibrator, Multi-Analyte Mixture LIGHT-BOOK · MAUDE
#839 of 1000 · 582 reports · 2000–2026
- BOOK 582 reports
- RANK #839 of 1000
- DEATH 0 death-typed
- INJ 8 injury-typed
- MALF 573 malfunction
- SPAN 2000–2026
- PEAK 2008: 173
- PHOTO Blood/Plasma Collecti…
Nearest event-volume peer: Blood/Plasma Collection Device For Dna Testing (1 report gap)
Calibrator, Multi-Analyte Mixture sits #839 of 1000 among tracked device types with 582 MAUDE reports spanning 2000–2026. 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
Calibrator, Multi-Analyte Mixture carries 98.5% MALFUNCTION-coded reports, 33.6pp 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 1.4% corpus 30.3% · below corpus mean (-28.9 pp)
- MALF 98.5% corpus 64.8% · above corpus mean (+33.6 pp)
Lead product-problem code High Test Results is 34% of coded problems · Lead manufacturer ABBOTT MANUFACTURING, INC. accounts for 66% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .
Calibrator, Multi-Analyte Mixture in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Mouthguard
Mouthguard, Prescription
584 reports
- Calibrator (this)
Calibrator, Multi-Analyte Mixture
582 reports
- Blood/Plasma…
Blood/Plasma Collection Device For Dna Testing
581 reports
- Culture Media
Culture Media, Non-Propagating Transport
581 reports
- Applier
Applier, Staple, Surgical,
580 reports
- Counter
Counter, Sponge, Surgical
579 reports
What this shows Calibrator, Multi-Analyte Mixture carries 582 MAUDE reports, ranked #839 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (18) held close to the prior two-year average of 14.
Related Entities for Calibrator, Multi-Analyte Mixture
Top Manufacturers
Event Locations
Compare ABBOTT MANUFACTURING, INC. vs ORTHO-CLINICAL DIAGNOSTICS →
Nationwide devices with a comparable report-volume footprint
Calibrator, Multi-Analyte Mixture 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 (582 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Calibrator, Multi-Analyte Mixture 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 Calibrator, Multi-Analyte Mixture; 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.