AU B96696Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 14987666543009), received between Nov 30, 2017 and Jun 3, 2026 — classified as 2 injuries, 127 malfunctions.

The most frequently reported specific device problem is “High Test Results” (55 reports).

1 FDA recall record name this device's identifier.

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. Apr 30, 2025Completed

   Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.

   Z-1908-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE AU680 CLINICAL CHEMISTRY GENERATED FALSE LOW PATIENT RESULTS FOR MULTIPLE CHEMISTRIES WHICH INCLUDES SODIUM (NA), POTASSIUM (K),CHLORIDE (CL), CALCIUM (CA), BLOOD UREA NITROGEN (BUN), MAGNESIUM (MG), ETHANOL (ETOH), ASPARTATE AMINOTRANSFERASE (AST), GLUCOSE (GLU), CREATININE (CREA), G-GLUTAMYL TRANSFERASE (GGT), TOTAL PROTEIN (TP), AND CARBON DIOXIDE (CO2) WITH "G" FLAGS. ALSO, THE CUSTOMER REPORTED. THE CUSTOMER ALSO INDICATED THAT THE ISSUE WAS FIRST OBSERVED DURING QUALITY CONTROL (QC) TESTING AND SUBSEQUENTLY AFFECTED PATIENT TESTING, THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE EXACT NUMBER OF ERRONEOUS RESULTS IS UNKNOWN AS PATIENT DATA WAS NOT AVAILABLE. VERBAL EXAMPLE OF RESULTS WAS PROVIDED 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 25374427 ↗
• MalfunctionMay 18, 2026High Readings

  THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH SODIUM (NA) PATIENT RESULTS AND STABILITY ERROR 3266 - ION SELECTIVE ELECTRODE (ISE) SERUM STANDARD SOLUTION H GENERATED ON THEIR AU680 ISE CLINICAL CHEMISTRY ANALYZER (PRODUCT NUMBER: B96696, SERIAL NUMBER: (B)(6). THERE WERE NO ERRONEOUSLY HIGH NA PATIENT RESULTS RELEASED OUTSIDE THE LABORATORY. THERE WAS NO INJURY, DEATH, OR DELAY/CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25207228 ↗
• MalfunctionApr 3, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW SODIUM PATIENT RESULTS WITH ANION GAP ISSUES ON THEIR AU680 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 24778808 ↗
• MalfunctionApr 2, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING HIGH PATIENT RESULTS WITH MULTIPLE FLAGS ON ION SELECTIVE ELECTRODE (ISE), SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) FOR THREE PATIENTS, INVOLVING THE AU680 CLINICAL CHEMISTRY ANALYZER. THE SAMPLES WERE REPEATED ON ANOTHER AU ANALYZER 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 PROVIDED RESULTS FOR THREE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772220 ↗
• MalfunctionMar 17, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW PATIENT AND QUALITY CONTROL RESULTS ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DID NOT SPECIFY THE AFFECTED ANALYTES. 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 24621793 ↗
• MalfunctionMar 6, 2026Low Test Results

  THE CUSTOMER REPORTED THE AU680 CLINICAL CHEMISTRY ANALYZER GENERATED ERRONEOUSLY LOW PATIENT RESULTS FOR SODIUM. 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 24536635 ↗
• MalfunctionFeb 10, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR ALKALINE PHOSPHATASE (ALP), ALANINE AMINOTRANSFERASE (ALT), CARBON DIOXIDE (CO2), CALCIUM ARSENAZO (CALA), TOTAL BILIRUBIN (TBIL) SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE SAMPLE WAS REPEATED ON A DIFFERENT AU ANALYZER WITH NORMAL RESULTS. THE LOW RESULTS WERE NOT REPORTED 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 24308663 ↗
• MalfunctionFeb 2, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW OR ZERO PATIENT RESULTS FOR MULTIPLE CHEMISTRIES ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE AFFECTED CHEMISTRY WAS NOT PROVIDED. THE PATIENT SAMPLES WERE REPEATED ON A DIFFERENT AU ANALYZER WITH NORMAL RESULTS. THE CUSTOMER DID NOT RELEASE THE 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 24242290 ↗
• MalfunctionJan 15, 2026Low Readings

  THE CUSTOMER REPORTED LOW PATIENT RESULTS ON MULTIPLE ANALYTES WITH G FLAGS INCLUDING AST (ASPARTATE AMINOTRANSFERASE), ALT (ALANINE AMINOTRANSFERASE), GLU (GLUCOSE), NA (SODIUM) K (POTASSIUM) AND CL (CHLORIDE) ON THEIR AU680 CHEMISTRY ANALYZER PART NUMBER B96696 AND INSTRUMENT SERIAL NUMBER (B)(6). THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, DEATH, OR DELAY/CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083344 ↗
• MalfunctionDec 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW ION SELECTIVE ELECTRODE (ISE) FOR SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE RE-ANALYZED 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. PROVIDED THE RESULTS FOR TWO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819502 ↗
• MalfunctionDec 4, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW SODIUM (NA) PATIENT RESULTS ON THEIR AU680 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 23720682 ↗
• MalfunctionNov 24, 2025High Test Results; High 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 AU680 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638172 ↗
• MalfunctionNov 12, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED RECOVERING LOW GLUCOSE (GLU) AND ION SELECTIVE ELECTRODE (ISE) RESULTS, WHICH INCLUDED SODIUM (NA) WHEN RUN ON THEIR AU680 CHEMISTRY ANALYZER (PN B96696, SN (B)(6)). THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533960 ↗
• MalfunctionOct 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE AU680 CLINICAL CHEMISTRY ANALYZER GENERATED APPROXIMATELY THIRTEEN (13) ERRONEOUSLY LOW PATIENT SAMPLE RESULTS FOR SODIUM (NA). THE CUSTOMER DID NOT PROVIDE PATIENT DATA 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 23344563 ↗
• MalfunctionAug 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING THREE PATIENT SAMPLE RESULTS ERRONEOUSLY HIGH FOR SODIUM (NA) ON THE ION SELECTIVE ELECTRODE (ISE) MODULE OF THE AU680 ANALYZER (PN B96696, SN (B)(6)). ONE OF THESE AFFECTED PATIENT SAMPLE RESULT WAS RELEASED FROM THE LABORATORY. THE CUSTOMER SUBSEQUENTLY RE-TESTED THE SAMPLE ON A DIFFERENT ANALYZER, OBTAINING ACCEPTABLE RESULTS, AND SUBMITTED A CORRECTIVE ACTION REPORT. THERE WAS NO REPORT OF CHANGES TO TREATMENT, INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDED PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22790057 ↗
• MalfunctionJul 11, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW PATIENT RESULTS FOR TOTAL BILIRUBIN (TBIL), DIRECT BILIRUBIN (DBIL), C-REACTIVE PROTEIN (CRP), AND ALANINE AMINOTRANSFERASE (ALT), WITH A ¿G¿ FLAG, ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE ANALYZER ALSO DISPLAYED MULTIPLE ERRORS, INCLUDING PHOTOCAL DATA ERRORS, CUVETTE MEAN CHECK ERRORS, AND PHOTOMETRY ERRORS. ADDITIONALLY, THE MID-STANDARD AND BUFFER SOLUTIONS WERE INDICATED AS EMPTY WITHOUT GENERATING THE EXPECTED WARNINGS. 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 22481469 ↗
• MalfunctionJun 12, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTED SIX PATIENTS HAD HIGH SODIUM RESULTS WITH A ¿PH¿ FLAG ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE REPEATED ON ANOTHER AU ANALYZER, RECOVERING NORMAL RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER VERBALLY PROVIDED RESULTS FOR ONLY ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197670 ↗
• MalfunctionMay 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ERRATIC GLUCOSE PATIENT RESULTS ON THEIR AU680 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 21970381 ↗
• MalfunctionMar 28, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE AU680 CLINICAL CHEMISTRY ANALYZER GENERATED ERRONEOUSLY LOW PATIENT RESULTS WITH 'G' FLAGS ON BLOOD UREA NITROGEN (BUN), CREATININE (CRE), CHLORIDE (CL), BICARBONATE (CO2), CALCIUM (CA), TOTAL PROTEIN (TP), ALBUMIN (ALB), ASPARTATE AMINOTRANSFERASE (AST), ALANINE AMINOTRANSFERASE (ALT), ALKALINE PHOSPHATASE (ALP) AND TOTAL BILIRUBIN (TBIL) FOR MULTIPLE PATIENTS. THE CUSTOMER PROVIDED EXAMPLE OF FALSE RESULTS FOR TWO (2) PATIENTS. 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 21721100 ↗
• MalfunctionMar 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER QUESTIONED ANION GAP (AGAP) ON PATIENT RESULTS GENERATED ON THEIR AU680 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 21694257 ↗
• MalfunctionFeb 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING FALSE LOW ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS WHICH INCLUDE SODIUM (NA), CHLORIDE (CL), AND POTASSIUM (K) ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS, AND THE 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 21403634 ↗
• MalfunctionFeb 18, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING TWO (2) FALSE LOW ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS WHICH INCLUDE SODIUM (NA), CHLORIDE (CL), AND POTASSIUM (K) ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS, AND THE 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 21400393 ↗
• MalfunctionFeb 5, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING FALSE LOW ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS WHICH INCLUDE SODIUM (NA), CHLORIDE (CL), AND POTASSIUM (K) ON THEIR AU680 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS, AND THE 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 21318218 ↗
• MalfunctionJan 10, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED THE AU680 CHEMISTRY ANALYZER GENERATED ERRONEOUS LOW ION SELECTIVE ELECTRODE (ISE), SODIUM (NA), CHLORIDE (CL), POTASSIUM (K), ALBUMIN (ALB), TOTAL PROTEIN (TP), AND ALKALINE PHOSPHATASE (ALP) PATIENT RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED TO THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132254 ↗
• MalfunctionNov 18, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW QUALITY CONTROL AND PATIENT RESULTS FOR ION SELECTIVE ELECTRODE ON SODIUM, POTASSIUM AND CHLORIDE ON THEIR AU680 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 20712399 ↗