System, Test, Automated Blood Grouping And Antibody
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 §864.9175 (Hematology panel).
FDA MAUDE casebook
openFDA event book System MID-BOOK · MAUDE
#213 of 1000 · 10,401 reports · 1994–2026
- BOOK 10,401 reports
- RANK #213 of 1000
- DEATH 6 death-typed
- INJ 100 injury-typed
- MALF 10,010 malfunction
- SPAN 1994–2026
- PEAK 2008: 1,047
- PHOTO Plate, Bone
Nearest event-volume peer: Plate, Bone (8 report gap)
System, Test, Automated Blood Grouping And Antibody sits #213 of 1000 among tracked device types with 10,401 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
System carries 96.2% MALFUNCTION-coded reports, 31.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 1.0% corpus 30.3% · below corpus mean (-29.3 pp)
- MALF 96.2% corpus 64.8% · above corpus mean (+31.4 pp)
Lead product-problem code False Negative Result is 52% of coded problems · Lead manufacturer ORTHO CLINICAL DIAGNOSTICS accounts for 67% of manufacturer-tagged reports · Top event location is 67% of location-tagged rows .
System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Stent
Stent, Superficial Femoral Artery
10,573 reports
- Appliance
Appliance, Fixation, Spinal Intervertebral Body
10,554 reports
- System (this)
System, Test, Automated Blood Grouping And Antibody
10,401 reports
- Plate, Bone
Plate, Bone
10,393 reports
- Catheter
Catheter, Coude
10,370 reports
- Prosthesis
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
10,195 reports
What this shows System, Test, Automated Blood Grouping And Antibody carries 10,401 MAUDE reports, ranked #213 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 fell to 66 in 2025, down from an average of 109 in the two years before.
Related Entities for System, Test, Automated Blood Grouping And Antibody
Top Manufacturers
Event Locations
Compare ORTHO CLINICAL DIAGNOSTICS vs ORTHO-CLINICAL DIAGNOSTICS →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (10,401 here).
Similar death-typed counts
Nearest other device types by death-typed report count (6 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System 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 System; 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.