Alinity 08P0424Recalls & reported problems
Abbott Ireland · Microalbumin 640 Tests · Class 1
- 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 00380740190781), received between Apr 21, 2025 and Apr 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Installation-Related Problem” (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
- Installation-Related Problem1
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.
MalfunctionApr 21, 2025Installation-Related Problem; Installation-Related Problem
THE CUSTOMER REPORTED THE URINE MICROALBUMIN ASSAY WAS CONFIGURED INCORRECTLY ON THE ALINITY C PROCESSING MODULE BY ABBOTT RESULTING IN FIVE PATIENT SAMPLES 10X HIGHER THAN PREVIOUS HISTORY. EXAMPLE RESULTS PROVIDED: SID (B)(6): RAW RESULT 0.769; RESULT REPORTED 7.6912 MG/DL. SID (B)(6): RAW RESULT: 17.618; RESULT REPORTED:176.1848 MG/DL. THE UOM SHOULD BE CONFIGURED ON THE ANALYZER TO BE UG/ML OR MG/L, NOT MG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21871297 ↗
Other TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) devices
- Alinity 08P0420Abbott GmbH · TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.