Alinity 04V3720Recalls & reported problems
Abbott Ireland Diagnostics · Alinity i STAT Myoglobin Reagent Kit 200 Tests · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740174903), received between Jun 11, 2026 and Jun 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Low Test Results
THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I MYOGLOBIN RESULTS GENERATED ON A 59YRS OLD MALE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6) NEW REAGENT=131.7 NG/ML /PREVIOUS REAGENT=163.8 NG/ML. LABORATORY REFERENCE RANGE FOR MYOGLOBULIN= < 140 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473336 ↗
Other MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL devices
- ARCHITECT 2K43-20Abbott Ireland Diagnostics · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 recall8 reports
- PATHFAST Myo-II N/APhc Corporation · Myoglobin, Antigen, Antiserum, Control1 recall0 reports
- Triage 97300EUQuidel Cardiovascular Inc. · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL8 reports
- VITROS 6801042Ortho Clinical Diagnostics · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL7 reports
- Alere Triage® 97000HSAlere San Diego, Inc. · Myoglobin, Antigen, Antiserum, Control6 reports
- Elecsys Myoglobin 07027583190Roche Diagnostics GmbH · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL6 reports
- Tinaquant Myoglobin Gen2 4580010190Roche Diagnostics GmbH · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 report
- Tina-quant Myoglobin Gen.2 08252629190Roche Diagnostics GmbH · MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.