AU B96697Recalls & reported problems

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 14987666543016), received between May 10, 2018 and Sep 29, 2026 — classified as 3 injuries, 283 malfunctions.

The most frequently reported specific device problem is “High Test Results” (149 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 286 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936080 ↗
• MalfunctionSep 29, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934687 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924963 ↗
• MalfunctionSep 23, 2026Low Test Results; Low Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873822 ↗
• MalfunctionSep 17, 2026Low Test Results

  The customer reported the generation of erroneously low Ion-selective Electrolytes (ISE) patient results, including Sodium (NA), Chloride (CL) and Potassium (K), on their AU5800 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 50808422 ↗
• MalfunctionJun 1, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH GLUCOSE (GLU) PATIENT RESULTS ON THEIR AU5800 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 TWO PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25350236 ↗
• MalfunctionMay 20, 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 AU5800 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 25229976 ↗
• MalfunctionMay 13, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH SODIUM PATIENT RESULTS ON THEIR AU5800 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 25162663 ↗
• MalfunctionMay 8, 2026Low Readings

  THE CUSTOMER QUESTIONED ERRATIC SODIUM (NA) PATIENT RESULTS GENERATED ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER (PN B9697, SN (B)(6)). THERE WERE NO ERRATIC NA PATIENT RESULTS RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO INJURY, DEATH, OR DELAY/CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA AND PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129009 ↗
• MalfunctionApr 30, 2026High Test Results

  CUSTOMER REPORTED THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED ONE (1) ERRONEOUS HIGH PATIENT RESULTS FOR ION SELECTIVE ELECTRODE (ISE) SODIUM (NA), POTASSIUM (K), CHLORIDE (CL). THE CUSTOMER ALSO INDICATED QUALITY CONTROLS (QC) WERE HIGH. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. 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 25053636 ↗
• MalfunctionApr 23, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH SODIUM (NA) PATIENT RESULTS WITH NEGATIVE ANION GAP ON THEIR AU5800 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 24974320 ↗
• MalfunctionApr 14, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING HIGH PATIENT RESULTS ON SODIUM, POTASSIUM AND CHLORIDE ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE NOT RELEASED OUTSIDE THE LABORATORY. THE CUSTOMER REPORTED THIS EVENT TO THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) FOR HIGH PATIENT RESULTS. 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 24876516 ↗
• MalfunctionMar 24, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR SODIUM AND CHLORIDE ON THEIR AU5800 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 24678866 ↗
• MalfunctionMar 23, 2026High Readings

  THE CUSTOMER REPORTED ISE (ION SELECTIVE ELECTRODE) SAMPLE POT OVERFLOW AND GENERATION OF ERRONEOUSLY HIGH ISE PATIENT AND QUALITY CONTROL (QC) RESULTS, ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER (PN B96697, SN (B)(6). THERE WERE NO ERRONEOUS ISE PATIENT RESULTS RELEASED OUTSIDE THE LABORATORY. THERE WAS NO ADVERSE EVENT, HARM, INJURY, EXPOSURE, CHANGE/DELAY IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663864 ↗
• MalfunctionMar 23, 2026Low Test Results

  THE CUSTOMER REPORTED GENERATION OF ERRONEOUSLY LOW ION SELECTIVE ELECTRODE (ISE) PATIENT RESULTS FOR SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL), ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER (PN B96697, SN (B)(6)). THE CUSTOMER INDICATED OBTAINING AN ISE DATA CONTROLLER ERROR. THE CUSTOMER RERAN THE PATIENT SAMPLES ON A SECONDARY ANALYZER WITH RESULTS WITHIN SPECIFIED RANGE. THERE WERE NO ERRONEOUS ISE PATIENT RESULTS RELEASED OUTSIDE OF THE LABORATORY. THERE IS NO REPORT OF ADVERSE EVENT, HARM, INJURY, EXPOSURE, DEATH, OR CHANGE/DELAY IN TREATMENT 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 24663777 ↗
• MalfunctionMar 20, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING AN ELEVATED NA, K AND CL PATIENT RESULT ON THE AU5800 CHEMISTRY ANALYZER. THE CUSTOMER REPORTED THIS ISSUE TO THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (NMPA) ADVERSE EVENT (AE) SYSTEM. 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 24656236 ↗
• MalfunctionMar 18, 2026Imprecise or Erratic Results

  THE CUSTOMER REPORTED GENERATION OF DATA CONTROLLER 3519 AND ISE SEQUENCE 3573 ERRORS AND ERRATIC SODIUM (NA) PATIENT RESULTS ON ISE CELL #2 OF THEIR AU5800 CLINICAL CHEMISTRY ANALYZER PN (B)(4), SN (B)(6). THERE WERE NO ERRATIC NA PATIENT RESULTS RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF HARM, INJURY, EXPOSURE, DEATH, OR CONFIRMED CHANGE/DELAY IN TREATMENT DUE TO THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24631651 ↗
• MalfunctionMar 9, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING HIGH PATIENT RESULTS ON ION SELECTIVE ELECTRODE (ISE) FOR SODIUM, POTASSIUM AND CHLORIDE ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER CELL 2. THE CUSTOMER ESTIMATED 220 PATIENT SAMPLES WERE REPEATED ON A DIFFERENT AU ANALYZER WITH NORMAL RESULTS. THE CUSTOMER REPORTED THE CORRECTED RESULTS OUTSIDE THE LABORATORY. 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 24553924 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED SAMPLE ID BARCODE READ ERRORS AND MULTIPLE PATIENT SAMPLES RESULTS WERE PROCESSED AND MISIDENTIFIED ON (B)(6) 2026 ON MORE THAN A THOUSAND TESTS OR MULTIPLE ASSAYS WHICH INCLUDED TOTAL BILIRUBIN (TBIL) AND SODIUM (NA). PATIENT DEMOGRAPHICS WERE UNAVAILABLE TO DETERMINE EACH PATIENT'S INDIVIDUAL STATUS; HOWEVER, IT WAS CONFIRMED THAT THIS MISIDENTIFICATION LED TO INSTANCES OF FALSE HIGH AND FALSE LOW NA AND TBIL RESULTS. THE EXACT NUMBER OF ERRONEOUS RESULTS GENERATED, AND ASSAYS IMPACTED COULD NOT BE DETERMINED DUE TO THE ABSENCE OF PATIENT CLINICAL INFORMATION. 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 24449603 ↗
• MalfunctionFeb 25, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED SAMPLE ID BARCODE READ ERRORS AND MULTIPLE PATIENT SAMPLES RESULTS WERE MISIDENTIFIED ON (B)(6) 2026 FOR MULTIPLE ASSAYS WHICH INCLUDED TOTAL BILIRUBIN (TBIL) AND SODIUM (NA). PATIENT DEMOGRAPHICS WERE UNAVAILABLE TO DETERMINE EACH PATIENT'S INDIVIDUAL STATUS; HOWEVER, IT WAS CONFIRMED THAT THIS MISIDENTIFICATION LED TO INSTANCES OF FALSE HIGH AND FALSE LOW NA AND TBIL RESULTS. THE EXACT NUMBER OF ERRONEOUS RESULTS GENERATED, AND ASSAYS IMPACTED COULD NOT BE DETERMINED DUE TO THE ABSENCE OF PATIENT CLINICAL INFORMATION. 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 24449578 ↗
• MalfunctionFeb 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS ERRATIC PATIENT RESULTS OF MULTIPLE ASSAYS WHICH INCLUDED CREATININE, ASPARTATE AMINOTRANSFERASE (AST), GLUCOSE AND OTHER ANALYTES WHICH WERE NOT PROVIDED. THE CUSTOMER REPORTED THE ISSUE TO NMPA WITH REPORT CODE (B)(4). THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHIC. 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 24284472 ↗
• MalfunctionFeb 2, 2026Unable to Obtain Readings

  THE CUSTOMER REPORTED THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED SAMPLE PROBE ERROR (CLOT SENSOR ERROR# 3217). UPON FOLLOW-UP, THE CUSTOMER DID NOT SPECIFY WHICH ASSAYS WERE AFFECTED. THERE WAS NO ERRONEOUS PATIENT RESULT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA AND/OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240987 ↗
• MalfunctionFeb 2, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING HIGH SODIUM PATIENT RESULTS ON THEIR AU5800 CELL 1 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 24240069 ↗
• MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ERRATIC SODIUM PATIENT RESULTS AND ION-SELECTIVE ELECTROLYTE (ISE) DATA CONTROLLER ERROR ON THEIR AU5800 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 24203412 ↗
• MalfunctionJan 22, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS HIGH PATIENT RESULTS FOR SODIUM (NA) INVOLVING THE AU5800 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS, AND NUMBER OF AFFECTED PATIENT SAMPLES 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 24151713 ↗