ARCHITECT 04T0920Recalls & reported problems
Abbott Ireland · Total Bilirubin2 900 Tests · Class 1
All models of ARCHITECT (38)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00380740167561), received between Sep 17, 2026 and Sep 17, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionSep 17, 2026Low Test Results
The customer reported falsely decreased Total Bilirubin2 results generated by the ARCHITECT c4000 Processing Module for an infant patient. The physician questioned the results associated with sample IDs (b)(6) . The following data was provided:Total Bilirubin reference range for infants: 2 to 12 mg/dL (b)(6) 2026 at 10:30 AM SID (b)(6)Total Bilirubin: 11.10 mg/dL.(b)(6) 2026 at 9:53 AM SID (b)(6)Total Bilirubin: 16.6 mg/dL.(b)(6) 2026 at 8:35 PM SID (b)(6)Total Bilirubin: 17.0 mg/dL.(b)(6) 2026 at 10:22 AM SID (b)(6)Total Bilirubin: 8.2 mg/dL.(b)(6) 2026 at 12:11 PM SID (b)(6)Total Bilirubin: 7.30 mg/dL.(b)(6) 2026 at 3:22 PM SID (b)(6)Total Bilirubin: 18.4 mg/dLThis sample was analyzed at another facility using the Alinity platform. (b)(6) 2026 at 11:22 AM SID (b)(6)Total Bilirubin: 19.10 mg/dL(b)(6) 2026 at 11:05 AM SID (b)(6)Total Bilirubin: 17.90 mg/dLResults marked with an asterisk (*) were questioned by the physician. No impact to patient management was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50801169 ↗
Other BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM devices
- ABL90 FLEX PLUS Analyzer 393-092Radiometer Medical ApS · BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM1 recall1 death175 reports
- ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents 10341113Siemens Healthcare Diagnostics Inc. · BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM1 recall0 reports
- Alinity 04V5121Abbott GmbH · BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM36 reports
- Drager Jaundice Meter, model JM-105 MU20105Draeger Medical Systems, Inc. · Bilirubin (Total And Unbound) In The Neonate Test System1 death23 reports
- 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
- Alinity 04U0520Abbott Ireland · BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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