Alinity 04U0520Recalls & reported problems
Abbott Ireland · Total Bilirubin2 3500 Tests · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740167585), received between Dec 4, 2025 and Jul 20, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 reports).
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
- High Test Results2
- Low Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2026High Test Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25879944 ↗MalfunctionJan 12, 2026High Test Results
THE CUSTOMER REPORTED FALSELY ELEVATED TOTAL BILIRUBIN2 RESULTS GENERATED BY THE ALINITY C PROCESSING MODULE FOR MULTIPLE PATIENTS. PHYSICIANS QUESTIONED THESE RESULTS AS THEY WERE INCONSISTENT WITH PRIOR PATIENT RESULTS. THE FOLLOWING DATA WERE PROVIDED: CUSTOMER¿S REFERENCE RANGE (ADULTS): 0.3 ¿ 1.2 MG/DL PATIENT 1 (72-YEAR-OLD FEMALE): (B)(6) 2025: 1.5 MG/DL. PREVIOUS ((B)(6) 2025): 0.5 MG/DL. PATIENT 2 (46-YEAR-OLD FEMALE): (B)(6) 2025: 2.1 MG/DL. PREVIOUS (B)(6) 2025): 0.3 MG/DL. PATIENT 3 (44-YEAR-OLD FEMALE): (B)(6) 2025: 2.6 MG/DL. PREVIOUS ((B)(6) 2025): 0.5 MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24038890 ↗MalfunctionDec 4, 2025Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY C TOTAL BILIRUBIN RESULTS FOR ONE 83-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), (B)(6) 2025 BILI T 0.38; REPEATED BILI T 0.45, (B)(6) 2025 BILI T 0.40. THE SAMPLE WAS SENT TO ANOTHER CAC LABORATORY: BILI T 0.50 (COLORIMETRIC METHOD). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715758 ↗
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- Alinity 04V5131Abbott GmbH · BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM13 reports
- ARCHITECT 7P32-21Abbott GmbH · BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM3 reports
- ARCHITECT 04T0920Abbott Ireland · BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.