AU B96698Recalls & reported problems

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 14987666543023), received between Feb 13, 2018 and Sep 10, 2026 — classified as 27 injuries, 233 malfunctions.

The most frequently reported specific device problem is “High Test Results” (100 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 260 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50723436 ↗
• MalfunctionAug 5, 2026High Test Results

  The customer reported the generation of erroneous high Glucose (GLU) results for twenty-nine (29) patients on their AU5800 Clinical Chemistry Analyzer. The samples were retested on another AU5800 analyzer with results considered correct. 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 29 patients,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147134 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The Beckman Field Service Engineer (FSE) sustained a fingernail injury during the de-installation of the AU5800 Analyzer. The FSE sought medical attention at the Emergency Room, where Cefprozil was prescribed to treat the damaged nail. The FSE was wearing gloves at the time of the incident. The FSE was able to return to work the following day without any restrictions. There was no death associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024556 ↗
• MalfunctionJun 23, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING HIGH PATIENT RESULTS FOR GLUCOSE (GLU), TOTAL BILIRUBIN (TBIL) AND TRIGLYCERIDE (TRIG) ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. THE SAMPLES WERE 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 ONLY PROVIDED THE GLU RESULTS FOR TWO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597922 ↗
• MalfunctionJun 11, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS WITH A ¿G¿ FLAG ON THE ION SELECTIVE ELECTRODE FOR SODIUM AND POTASSIUM INVOLVING THE 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. NOTE: A ¿G¿ FLAG INDICATES A RESULT IS LOWER THAN THE DYNAMIC RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477840 ↗
• MalfunctionJun 5, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF FALSE HIGH ISE (ION SELECTIVE ELECTRODES) PATIENT RESULTS FOR SODIUM (NA) ON THEIR AU5800 CHEMISTRY ANALYZER CELL 1 AND 2. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND LATER AMENDED. THE CUSTOMER PROVIDED VERBAL EXAMPLE OF RESULTS FOR TWO(2) PATIENT SAMPLES. 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 25411482 ↗
• MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED OF GETTING ERRONEOUS PATIENT RESULTS FOR ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS WHICH INCLUDE SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) WITH LOW ANION GAPS ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. 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 25340514 ↗
• MalfunctionMay 22, 2026High Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC ION SELECTIVE ELECTRODE (ISE) PATIENT RESULTS INCLUDING SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) AND FAILING QUALITY CONTROL (QC) ON BOTH CELL 1 AND CELL 2, ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER (PRODUCT NUMBER (B)(4), SERIAL NUMBER (B)(6)). THERE WERE NO ERRATIC ISE PATIENT RESULTS REPORTED OUTSIDE OF 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 25257145 ↗
• MalfunctionMay 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED OF GETTING ERRONEOUS ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS FOR SODIUM (NA), POTASSIUM (K) AND CHLORIDE CL) WITH LOW ANION GAP ON THEIR AU5800 CHEMISTRY ANALYZER. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25193134 ↗
• MalfunctionMay 12, 2026High Test Results

  THE CUSTOMER REPORTED THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED APPROXIMATELY THIRTY (30) ERRONEOUS HIGH ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS FOR SODIUM (NA) AND POTASSIUM (K). 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 25152803 ↗
• MalfunctionMay 12, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS LOW SODIUM PATIENT RESULTS ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPEATED THE SAMPLE AND OBTAINED A RESULT CONSIDERED CORRECT BY THE CUSTOMER; THEREFORE, 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 25152273 ↗
• MalfunctionMay 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC QUALITY CONTROL AND PATIENT RESULTS FOR GLUCOSE, ALBUMIN AND CHOLINESTERASE 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 25151700 ↗
• MalfunctionMay 8, 2026High Test Results

  THE CUSTOMER REPORTED GENERATION OF ERRONEOUS PATIENT RESULTS FOR BLOOD UREA NITROGEN (BUN) AND GLUCOSE (GLU) ON THEIR AU5800 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 DID NOT PROVIDE PATIENT DATA AND PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128886 ↗
• MalfunctionMay 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED HAVING QUESTIONABLE PATIENT RESULTS FOR MULTIPLE ANALYTES WHICH INCLUDES GLUCOSE (GLU), C- REACTIVE PROTEIN NORMAL (CRPN), IRON (FE), LACTATE DEHYDROGENASE (LDH), CREATINE KINASE (CK), AND HAPTOGLOBIN (HAPT) ON THEIR AU5800 CHEMISTRY ANALYZER. THE CUSTOMER REPEATED PATIENT SAMPLES ON ANOTHER ANALYZER AND RESULTS WERE CORRECTED. THE CUSTOMER DID NOT PROVIDE PATIENT DATA, OR DEMOGRAPHICS AND THE EXACT NUMBER OF PATIENT SAMPLES 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 25110687 ↗
• MalfunctionMay 1, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED FOURTEEN (14) FALSE LOW SODIUM (NA), AND HIGH CHLORIDE (CL) PATIENT RESULTS WITH NEGATIVE ANION GAP. 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. THE CUSTOMER PROVIDE PATIENT DATA FOR (14) PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059976 ↗
• MalfunctionApr 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC SODIUM PATIENT RESULTS DUE TO LOW ANION GAP VALUES ON THEIR CELL 2 OF AU5800 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER ESTIMATED 15 PATIENTS HAD ERRATIC RESULTS, BUT THEY WERE NOT RELEASED 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 25052477 ↗
• MalfunctionApr 29, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW SODIUM PATIENT RESULTS AND QUALITY CONTROL ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. THE LOW RESULTS WERE NOT RELEASED 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 25034918 ↗
• InjuryApr 23, 2026High Test Results

  ON 25MAR2026, THE CUSTOMER REPORTED THAT A PATIENT¿S ENZYMATIC CREATININE (CREA) ASSAY, TESTED ON THEIR AU5800 CHEMISTRY ANALYZER, SHOWED FALSELY HIGH RESULTS. THE CUSTOMER ATTRIBUTED HIGH RESULTS TO IGM PARAPROTEIN INTERFERENCE WITHIN ENZYMATIC CREATININE ASSAY. WHEN THE SAMPLE WAS DILUTED AND TESTED ON DIFFERENT (NON-BECKMAN) ANALYZERS, THE RESULTS WERE LOWER. DUE TO HIGH RESULTS BEING RELEASED OUTSIDE THE LABORATORY, THE PATIENT WAS RECOMMENDED TO A RENAL REFERRAL. THE WAS NO REPORT OF HARM OR DEATH ASSOCIATED WITH THIS EVENT. BY 14APR2026, UPON OBTAINING ADDITIONAL INFORMATION, BECKMAN COULTER BECAME AWARE THAT THE PATIENT WAS THEN SENT TO THE EMERGENCY DEPARTMENT (ED). THE CUSTOMER COULD NOT CONFIRM WHETHER THE PATIENT RECEIVED ANY TREATMENT WHILE AT THE ED. THE CUSTOMER ONLY INDICATED THAT THE PATIENT¿S CHRONIC KIDNEY DISEASE STAGE WAS CHANGED FROM STAGE 3B TO 4. NO FURTHER DETAILS WERE PROVIDED. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971068 ↗
• MalfunctionApr 22, 2026High Readings

  THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH GLUCOSE (GLU) PATIENT RESULTS GENERATED ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER (PN: B96698, SN: (B)(6). NO ERRONEOUSLY HIGH GLU PATIENT RESULTS WERE RELEASED OUTSIDE THE LABORATORY. THERE WAS NO INJURY, DEATH, OR DELAY/CHANGE 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 24955671 ↗
• MalfunctionApr 21, 2026High Readings

  THE CUSTOMER REPORTED OBTAINING FALSE HIGH SODIUM (NA) AND CHLORIDE (CL) PATIENT RESULTS FOR FIFTEEN (15) PATIENTS, ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER (PN B96698, SN (B)(6). THE CUSTOMER REPEATED THE SAMPLE ON ANOTHER SYSTEM AND OBTAINED A RESULT CONSIDERED CORRECT BY THE CUSTOMER. 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 24945345 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OF GETTING ERRONEOUS PATIENT RESULTS FOR SODIUM AND CHLORIDE WITH NEGATIVE ANION GAPS ON CELL 2 OF THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. 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 24918639 ↗
• InjuryApr 17, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW MAGNESIUM (MG) PATIENT RESULTS WITH A ¿G¿ FLAG ON THEIR AU5800 CLINICAL CHEMISTRY ANALYZER. REPEAT TESTING WAS RUN ON THE SAME ANALYZER AND A DIFFERENT ANALYZER WITH RESULTS WERE HIGHER. THE INITIAL LOW RESULT WAS RELEASED OUTSIDE THE LABORATORY. THE CUSTOMER INDICATED THERE WAS A CHANGE IN PATIENT TREATMENT. THE PATIENT RECEIVED INTRAVENOUS (IV) FLUID TREATMENT FOR MG. NO HARM TO THE PATIENT WAS REPORTED. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS BUT PROVIDED RESULTS FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918348 ↗
• MalfunctionApr 13, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY LOW TOTAL BILIRUBIN (TBIL), C-REACTIVE PROTEIN (CRP), AND ALANINE AMINOTRANSFERASE (ALT) 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 24864890 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ERRATIC 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 24745126 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ERRATIC 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 24700534 ↗