AU B96693Recalls & reported problems

Summary

The FDA's MAUDE database contains 327 adverse event reports that list this exact device (DI 14987666542972), received between Apr 20, 2018 and Sep 8, 2026 — classified as 12 injuries, 315 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (140 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 25 most recent of 327 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679875 ↗
• MalfunctionAug 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166002 ↗
• MalfunctionJun 3, 2026Imprecise or Erratic Results

  THE CUSTOMER REPORTED OF GETTING ERRONEOUS ERRATIC PATIENT RESULTS FOR ION SELECTIVE ELECTRODE (ISE) WHICH INCLUDES SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) WITH LOW ANION GAPS ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER (PN B96693, SN (B)(6). THE ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF LABORATORY. THERE WERE NO INJURIES, DEATHS, OR DELAYS/CHANGES IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPEATED PATIENT SAMPLES ON ANOTHER ANALYZER AND OBTAINED RESULTS CONSIDERED CORRECT BY THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE PATIENT DATA AND/OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25379677 ↗
• MalfunctionMay 29, 2026Low Test Results

  CUSTOMER REPORTED OF GETTING ERRONEOUS LOW PATIENT RESULTS WITH SHORT SAMPLE ERRORS FOR MULTIPLE ANALYTES WHICH INCLUDED ALBUMIN (ALB), BLOOD UREA NITROGEN, CALCIUM, CARBON DIOXIDE, CHLORIDE, CREATININE, GLUCOSE, POTASSIUM, SODIUM, TOTAL BILIRUBIN, PROTEIN, ALANINE AMINOTRANSFERASE, ALKALINE PHOSPHATASE AND ASPARTATE AMINOTRANSFERASE ON THE AU480 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR PATIENT DEMOGRAPHICS, AND THE EXACT NUMBER OF PATIENTS AFFECTED IS UNKNOWN. THE CUSTOMER ONLY PROVIDED AN EXAMPLE FOR TWO (2) PATIENTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340755 ↗
• MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ONE (1) ERRONEOUS LOW PATIENT RESULT FOR MULTIPLE ASSAYS WHICH INCLUDED ALT (ALANINE AMINOTRANSFERASE), GLU (GLUCOSE), CRE (CREATININE), CK (CREATINE KINASE), NA (SODIUM), K (POTASSIUM) AND CL (CHLORIDE) AFTER PM (PREVENTATIVE MAINTENANCE) WAS PERFORMED INVOLVING THE AU480 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340494 ↗
• MalfunctionMay 19, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH POTASSIUM AND SODIUM PATIENT RESULTS ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222162 ↗
• MalfunctionMay 15, 2026Low Test Results

  THE CUSTOMER REPORTED ERRONEOUS LOW PATIENT RESULTS GENERATED FOR LIPASE (LIP), BICARBONATE (CO2) AND ION SELECTIVE ELECTRODE (ISE) WHICH INCLUDE SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND LATER AMENDED. THE CUSTOMER DID NOT PROVIDE PATIENT DATA PRINTOUTS OR DEMOGRAPHICS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194588 ↗
• MalfunctionMay 13, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW SODIUM AND CHLORIDE PATIENT RESULTS ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE DEMOGRAPHICS. DATA WAS PROVIDED FOR ONE PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162943 ↗
• MalfunctionMay 9, 2026Low Test Results

  CUSTOMER REPORTED OF GETTING ERRONEOUS PATIENT RESULTS FOR SODIUM AND POTASSIUM INVOLVING THEIR AU480 CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25131647 ↗
• MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED OF GETTING ERRONEOUS PATIENT RESULTS FOR SODIUM, POTASSIUM AND CHLORIDE ON THEIR AU480 CHEMISTRY ANALYZER. THE ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980921 ↗
• MalfunctionApr 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER QUESTIONED AN ACETAMINOPHEN RESULT WITH '*' FLAG FOR ONE PATIENT SAMPLE GENERATED ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971637 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC PATIENT RESULTS ON ION SELECTIVE ELECTRODE (ISE) INCLUDING SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918134 ↗
• MalfunctionApr 3, 2026Low Test Results

  A CUSTOMER REPORTED THAT THEIR AU480 CLINICAL CHEMISTRY ANALYZER PRODUCED LOW PATIENT RESULTS FOR CREATININE, SODIUM, AND POTASSIUM. THE SAME SAMPLE WAS RE-TESTED AND YIELDED NORMAL RESULTS. ALTHOUGH THE INITIAL LOW RESULTS WERE RELEASED, THEY WERE SUBSEQUENTLY AMENDED AFTER THE REPEAT TESTING. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778625 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE AU480 CLINICAL CHEMISTRY ANALYZER GENERATED FOUR (4) ERRONEOUS ERRATIC PATIENT RESULTS FOR ION SELECTIVE ELECTRODE (ISE) WHICH INCLUDES SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) WITH LOW ANION GAPS AND ISE DRAIN OVERFLOWING. THE CUSTOMER DID NOT PROVIDE PATIENT PRINTOUT OR DEMOGRAPHICS. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746357 ↗
• MalfunctionMar 26, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH ION-SELECTIVE ELECTROLYTES (ISE) PATIENT RESULTS, INCLUDING SODIUM (NA), CHLORIDE (CL) AND POTASSIUM (K), ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. DATA WAS PROVIDED FOR THREE (3) PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700463 ↗
• MalfunctionMar 25, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS WITH MULTIPLE FLAGS FOR SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), BLOOD UREA NITROGEN (BUN), CREATININE (CREA) AND C-REACTIVE PROTEIN (CRP) ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THE SAMPLE WAS REPEATED WITH NORMAL RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS BUT SHARED THE RESULTS WITH ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24693407 ↗
• MalfunctionMar 25, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR SODIUM AND TOTAL PROTEIN ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691514 ↗
• MalfunctionMar 23, 2026Low Test Results

  THE CUSTOMER REPORTED GENERATION OF ERRONEOUS LOW SODIUM (NA), AND CHLORIDE (CL) PATIENT RESULTS ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER (PN B96693, SN (B)(6). THERE WAS NO INJURY, DEATH, OR DELAY/CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE ANY PATIENT DATA AND/OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663936 ↗
• MalfunctionMar 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER QUESTIONED PATIENT RESULTS FOR SODIUM (NA), CHLORIDE, POTASSIUM (K) AND CO2 RESULTS DUE TO LOW ANION GAP RESULTS INVOLVING THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS, OR DATA AND THE EXACT NUMBER OF PATIENTS AFFECTED IS UNKNOWN. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654617 ↗
• MalfunctionMar 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING ERRATIC PATIENT RESULTS FOR ION SELECTIVE ELECTRODE (ISE) INCLUDING SODIUM, POTASSIUM AND CHLORIDE INVOLVING THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613132 ↗
• MalfunctionMar 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ERRATIC PATIENT RESULTS FOR MULTIPLE ANALYTESM INCLUDING, LIPID PANELS AND CMP (COMPREHENSIVE METABOLIC PANEL) WITH CALIBRATION ISSUES, RB (REAGENT BLANK) DATA ERROR, INCORRECT CUVETTE ERRORS AND OTHER MAINTENANCE ALERTS ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571486 ↗
• MalfunctionMar 9, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED OF GETTING ERRATIC PATIENT RESULTS FOR SODIUM AND CHLORIDE INVOLVING THE AU480 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND LATER CORRECTED. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550822 ↗
• MalfunctionMar 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED A SAMPLE PROBE ERROR ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. AS RESULT, FIVE PATIENTS HAD ERRATIC RESULTS ON ION SELECTIVE ELECTRODE (ISE) INCLUDING SODIUM, POTASSIUM AND CHLORIDE. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503775 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRATIC ERRONEOUS PATIENT RESULTS ON MULTIPLE ASSAYS WHICH INCLUDES UREA NITROGEN (UREA), CREATININE (CRE) AND SODIUM (NA), INVOLVING THE AU480 CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442312 ↗
• MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED OF GETTING ERRONEOUS ERRATIC PATIENT RESULTS FOR CARBON DIOXIDE (CO2), SODIUM (NA), AND CHLORIDE (CL) WITH LOW ANION GAPS ON THEIR AU480 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS, AND THE EXACT NUMBER OF PATIENTS AFFECTED IS UNKNOWN. THE CUSTOMER PROVIDED A VERBAL EXAMPLE OF FALSE RESULTS FOR ONE (1) PATIENT. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388530 ↗