AU B96692Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14987666542965), received between Jan 21, 2021 and Apr 22, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 3, 2026Open, Classified

   Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient results.

   Z-3332-2026 · Root cause: Software design · FDA record ↗

2. Apr 30, 2025Completed

   A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.

   Z-1907-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Low Test Results

  THE CUSTOMER REPORTED CONTINUED G RESULT FLAG ERRORS ON THEIR AU 480 CLINICAL CHEMISTRY ANALYZER (PN: B96692, SN: (B)(6) AND LOW RESULTS DURING FENTANYL TESTS, WHICH WERE NOT RESOLVED THROUGH DILUTIONS OR ROUTINE MAINTENANCE. THERE WAS NO ADVERSE EVENT, NO HARM, INJURY, EXPOSURE, DEATH, OR CONFIRMED CHANGE/DELAY ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA, AND / OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955935 ↗
• MalfunctionApr 8, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRATIC PATIENT RESULTS GENERATED FOR MULTIPLE ANALYTES WHICH INCLUDED UALB (URINE ALBUMIN), ALP (ALKALINE PHOSPHATASE), CALA (CALCIUM), CRE (CREATININE), GGT (GAMMA-GLUTAMYL TRANSFERASE), GLUC (GLUCOSE), TP (TOTAL PROTEIN), UREA, D-DIM (D- DIMER), UA (URIC ACID) AND OBSERVED SAMPLE PROBE DILUTING SAMPLES ON SYSTEM AU480 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF LABORATORY. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT. QUALITY CONTROL WAS WITHIN THE LABORATORY¿S ESTABLISHED RANGES PRIOR TO EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638336 ↗
• MalfunctionJan 21, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED INTERMITTENT LOW GLUCOSE (GLU), CREATININE (CRE), AND ALANINE AMINOTRANSFERASE (ALT) PATIENT RESULTS ON THE AU480 CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT. QUALITY CONTROL (QC) WERE WITHIN LABORATORY¿S ESTABLISHED RANGE PRIOR TO AND AFTER THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206333 ↗