DxC AU B86444Recalls & reported problems

Summary

The FDA's MAUDE database contains 588 adverse event reports that list this exact device (DI 14987666542545), received between Jul 18, 2018 and Sep 30, 2026 — classified as 1 death, 61 injuries, 526 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (280 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 588 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Insufficient Information

  MAUDE report 50952696 ↗
• MalfunctionSep 30, 2026Low Test Results

  The customer reported the generation of erroneously low Sodium (NA) patient results on their DxC 700 AU 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 three patient samples.

  Patient problems: Insufficient Information

  MAUDE report 50949330 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938366 ↗
• MalfunctionSep 23, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872158 ↗
• InjuryJun 23, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR GLUCOSE, ALBUMIN, AND MAGNESIUM ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE RELEASED OUTSIDE THE LABORATORY. THE CUSTOMER INDICATED A CHANGE IN PATIENT MANAGEMENT, WHERE THE PATIENT WAS STARTED ON MAGNESIUM MEDICATION, WHICH WAS THEN DISCONTINUED AFTER CORRECTED RESULTS WERE AMENDED. BECKMAN COULTER CONTACTED THE CUSTOMER FOR MORE DETAILS, BUT THEY DECLINED TO PROVIDE ADDITIONAL PATIENT INFORMATION. HOWEVER, THEY CONFIRMED THE PATIENT WAS NOT HARMED. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593517 ↗
• MalfunctionJun 23, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH PATIENT RESULTS FOR SODIUM(NA) AND BICARBONATE (CO2) WITH LOW ANION GAP ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25593510 ↗
• MalfunctionJun 23, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW PATIENT RESULTS FOR GLUCOSE (GLU), SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) ANALYTES ON THEIR DXC700AU ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS, 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 25593509 ↗
• MalfunctionJun 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC THREE (3) PATIENT RESULTS FOR SODIUM (NA), AND CHLORIDE (CL) DUE TO NEGATIVE ANION GAP VALUES, ON THE DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS BUT PROVIDED THE RESULTS FOR ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522663 ↗
• MalfunctionJun 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC PATIENT RESULTS ON ION SELECTIVE ELECTRODE FOR SODIUM, POTASSIUM AND CHLORIDE DUE TO LOW ANION GAP VALUES, INVOLVING THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE RELEASED OUTSIDE THE LABORATORY. HOWEVER, THE CUSTOMER INDICATED 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 25479238 ↗
• MalfunctionJun 11, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR MAGNESIUM, PHOSPHORUS, GLUCOSE AND SODIUM ON THEIR DXC 700 AU 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 25477146 ↗
• MalfunctionJun 8, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING FALSE LOW TOTAL BILIRUBIN (TBIL) PATIENT RESULT FOR ONE PATIENT, ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER (PART NUMBER (PN) B86444, SERIAL NUMBER (SN) (B)(6). THE CUSTOMER REPEATED THE SAMPLE 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 25436085 ↗
• MalfunctionJun 8, 2026Imprecise or Erratic Results

  THE CUSTOMER REPORTED OBTAINING FALSE HIGH SODIUM (NA), POTASSIUM (K), AND CHLORIDE (CL) PATIENT RESULTS GENERATED WITH LOW ANION GAP CALCULATION VALUES ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER (PART NUMBER (PN) B86444, SERIAL NUMBER (SN) (B)(6). THE CUSTOMER REPEATED THE SAMPLE 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 25433844 ↗
• MalfunctionJun 5, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS FOR MULTIPLE CHEMISTRIES INCLUDING SODIUM, CHLORIDE, TOTAL PROTEIN, ASPARTATE AMINOTRANSFERASE, MAGNESIUM, BLOOD UREA NITROGEN, GLUCOSE AND PHOSPHORUS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE PATIENT SAMPLE WAS REPEATED ON A DIFFERENT 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 DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25416298 ↗
• MalfunctionJun 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC SODIUM PATIENT RESULTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THOSE ERRATIC 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 25399621 ↗
• MalfunctionMay 29, 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 DXC 700 AU 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 25333986 ↗
• MalfunctionMay 28, 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 DXC 700 AU 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 25320842 ↗
• MalfunctionMay 26, 2026Imprecise or Erratic Results

  THE CUSTOMER QUESTIONED THE GENERATION OF SODIUM (NA) PATIENT RESULTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER (PRODUCT NUMBER: B86444, SERIAL NUMBER: (B)(6). THE CUSTOMER REPORTED THAT NA PATIENT RESULTS RANGED BETWEEN 134-142 MMOL/L AND REPEATED +/- 5 MMOL/L ON RERUN TESTS. THERE WERE NO QUESTIONED NA PATIENT RESULTS RELEASED OUTSIDE OF 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 25295414 ↗
• MalfunctionMay 22, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF FALSE LOW PATIENT RESULTS FOR SODIUM (NA) AND CHLORIDE (CL) WITH LOW ANION GAPS AND ALSO NOTED THAT MIX BAR MAKING NOISE ON THEIR DXC 700 AU 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 25262529 ↗
• MalfunctionMay 22, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING HIGH SODIUM (NA) PATIENT RESULTS WITH AN ¿H¿ FLAG ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER RELEASED EIGHT PATIENTS RESULTS OUTSIDE THE LABORATORY; HOWEVER, THOSE RESULTS WERE AMENDED UPON REPEAT TESTING. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS BUT ONLY SHARED VERBAL RESULTS FOR TWO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257651 ↗
• MalfunctionMay 22, 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 DXC 700 AU 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 25256897 ↗
• InjuryMay 21, 2026Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED ON THEIR DXC 700 ANALYZER WHERE THE WASTE DRAIN GENERATED FOAM AND OVERFLOWED, MAKING THE FLOOR SLIPPERY. AS A RESULT, A LABORATORY OPERATOR SLIPPED, FELL AND SUSTAINED INJURIES TO THEIR BACK AND LEG. AT THE TIME OF THE INCIDENT, THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THE OPERATOR SOUGHT URGENT CARE AND BEGAN PHYSICAL THERAPY. IT IS UNKNOWN IF MEDICATION WAS PRESCRIBED. THE OPERATOR RETURNED TO WORK ON (B)(6) 2026, WITH WORK RESTRICTIONS. NO ADDITIONAL DETAILS WERE PROVIDED. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: Back pain

  MAUDE report 25250169 ↗
• MalfunctionMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC PATIENT RESULTS ON SODIUM (NA) AND CHLORIDE (CL) DUE TO LOW ANION GAP VALUES INVOLVING THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE ERRATIC 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 25247135 ↗
• MalfunctionMay 21, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS LOW SODIUM PATIENT RESULTS ON THEIR DXC 700 AU 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 25244650 ↗
• MalfunctionMay 19, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW PATIENT RESULTS WITH A ¿G¿ FLAG FOR MULTIPLE CHEMISTRIES INCLUDING SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), BICARBONATE (CO2), GLUCOSE (GLU), TOTAL PROTEIN (TP), TOTAL BILIRUBIN (TBIL), ALBUMIN (ALB), CREATININE (CREAT), CALCIUM (CA), BLOOD UREA NITROGEN (BUN), ASPARTATE AMINOTRANSFERASE (AST), ALKALINE PHOSPHATASE (ALP), AND ALANINE AMINOTRANSFERASE (ALT) INVOLVING THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. 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 DEMOGRAPHICS BUT SHARED ONLY THE INITIAL RESULTS FOR TWO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224197 ↗
• MalfunctionMay 18, 2026Imprecise or Erratic Results

  THE CUSTOMER REPORTED OBTAINING ONGOING ERRONEOUS ZERO RESULTS WITH ¿G¿ FLAGS FOR PATIENT SAMPLES ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER (PRODUCT NUMBER B86444, SERIAL NUMBER (B)(6). UPON FOLLOW-UP, THE CUSTOMER SPECIFIED ALL ASSAYS WERE IMPACTED. THERE WAS NO ERRONEOUS PATIENT RESULT 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 DATA AND/OR PATIENT DEMOGRAPHICS. NOTE: PER DXC 700 AU CHEMISTRY ANALYZER INSTRUCTIONS FOR USE (IFU) GUIDE B71495AF: O FLAG ¿G¿: RESULT IS LOWER THAN THE ANALYTICAL MEASURING RANGE. O FLAG ¿/¿: TEST PENDING OR NOT ANALYZED. O FLAG ¿?¿: UNABLE TO CALCULATE A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25204175 ↗