DxC AU B86446Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 14987666542514), received between Jul 30, 2021 and Sep 10, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722874 ↗
• MalfunctionJun 2, 2026High Test Results

  THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY HIGH PATIENT RESULTS FOR SODIUM (NA) ANALYTE ON THREE OF THE TEN SAMPLES ON THEIR DXC700AU CLINICAL CHEMISTRY ANALYZER (PN B86446, SN (B)(6). THERE WAS NO REPORT OF INJURY, DEATH, DELAY OR CHANGE IN TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25362290 ↗
• MalfunctionApr 22, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW SODIUM (NA) PATIENT RESULTS GENERATED ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER (PN 60377051, SN (B)(6). THERE WERE NO ERRONEOUSLY LOW 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/OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960310 ↗
• MalfunctionApr 22, 2026High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH 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 24959123 ↗
• MalfunctionApr 22, 2026High Readings

  THE CUSTOMER REPORTED FALSE HIGH SODIUM PATIENT RESULTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER INDICATED THE RESULTS WERE HIGHER COMPARED TO THEIR SECOND 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 24955173 ↗
• MalfunctionApr 21, 2026Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW SODIUM (NA) RESULTS FOR 10 PATIENTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE SAMPLES WERE REPEATED WITH HIGHER 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 SHARED THE RESULTS FOR ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947248 ↗
• MalfunctionApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC SODIUM PATIENT RESULTS ON 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 24916156 ↗
• MalfunctionApr 17, 2026Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF LOW RESULTS WITH G FLAG FOR MULTIPLE ASSAYS INCLUDING, ALB (ALBUMIN), TBC (TOTAL BILIRUBIN), DBC (DIRECT BILIRUBIN), CHOL (CHOLESTEROL), TRG (TRIGLYCERIDE) FOR ONE PATIENT SAMPLE, ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. PATIENT SAMPLES WERE REPEATED WITH RESULTS CONSIDERED NORMAL. 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 24912498 ↗
• InjuryMar 20, 2026Low Test Results

  THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY LOW PATIENT RESULTS WITH (G) FLAG ON A FOUR-MONTH-OLD BABY PATIENT SAMPLE FOR TRIGLYCERIDES (TRIG), PHOSPHOROUS (PHOS), UREA NITROGEN (BUN), AND PROTEIN ON THEIR DXC700AU CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS A REPORT OF CHANGE IN PATIENT TREATMENT, THE PATIENT RECEIVED INTRAVENOUS (IV) INFUSION TREATMENT DUE TO FALSE RESULTS. THE PATIENT SAMPLE WAS REDRAWN, AND TREATMENT STOPPED AFTER RECEIVING NEW RESULTS WHICH WERE CONSIDERED CORRECT BY THE CUSTOMER. THERE WAS NO REPORT OF DEATH ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24649541 ↗
• MalfunctionDec 2, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED OBTAINING LOW SODIUM PATIENT RESULTS ON THEIR DXC 700 AU 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 THE RESULT FOR ONE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697996 ↗
• MalfunctionJun 23, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS NEGATIVE OR NO VALUE PATIENT RESULTS GENERATED FOR MULTIPLE ANALYTES WHICH INCLUDES ALT (ALANINE AMINOTRANSFERASE), CHOL (CHOLESTEROL), HDL (HDL CHOLESTEROL), TRIG (TRIGLYCERIDES), TP (TOTAL PROTEIN), UREA, NA (SODIUM), K (POTASSIUM), CALC (CALCIUM) AND IGA (IMMUNOGLOBULIN A) 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 DEMOGRAPHICS. THE CUSTOMER PROVIDED THE FOLLOWING DATA (REFER TO ATTACHED PATIENT DATA SUMMARY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311961 ↗
• MalfunctionFeb 21, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF FALSE LOW PATIENT RESULTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER DID NOT SPECIFY THE AFFECTED ANALYTE. 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 21439112 ↗
• InjuryNov 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH CREATININE (CRE) RESULTS FOR ONE (1) NEONATAL PATIENT SAMPLE INVOLVING THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS HIGH PATIENT RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND LATER CORRECTED. THE PATIENT SURGERY WAS POSTPONED AND PUT ON INFUSION DUE TO FALSE CREATININE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20670351 ↗
• InjuryNov 12, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH CREATININE (CRE) RESULTS FOR ONE (1) FEMALE NEONATAL PATIENT SAMPLE INVOLVING THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE NEONATAL FEMALE PATIENT WAS BORN IN (B)(6) 2023 HAD BEEN DIAGNOSED WITH ALVEOLAR RHABDOMYOSARCOMA AND WAS RECEIVING CHEMOTHERAPY TREATMENT. DUE TO THE WORSENING KIDNEY FUNCTION, THE PATIENT HOSPITALIZATION WAS PROLONGED. THE PATIENT HOSPITALIZATION WAS PROLONGED DUE TO FALSE HIGH CRE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20670326 ↗
• MalfunctionSep 23, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH SODIUM (NA) PATIENT RESULTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER ON (B)(6) 2024. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER WITH LOWER RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED PATIENT DATA. NOTE: REFERENCE BECKMAN COULTER IDENTIFIER (B)(4) WHICH ADDRESSES THE ERRONEOUS RESULTS GENERATED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20286951 ↗
• MalfunctionSep 23, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH SODIUM (NA) PATIENT RESULTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER ON (B)(6) 2024. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER WITH LOWER RESULTS. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. THE CUSTOMER PROVIDED PATIENT DATA. NOTE: REFERENCE BECKMAN COULTER IDENTIFIER (B)(4) WHICH ADDRESSES THE ERRONEOUS RESULTS GENERATED ON 10-SEP-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20284819 ↗
• MalfunctionAug 13, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH SODIUM (NA) RESULTS FOR FIVE (5) PATIENTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE SAMPLES WERE REPEATED WITH RESULTS CONSIDERED CORRECT. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY; HENCE, 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 19974638 ↗
• MalfunctionAug 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING ERRATIC PATIENT RESULTS ON ION SELECTIVE ELECTRODE (ISE) SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) INVOLVING 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 19956244 ↗
• MalfunctionAug 28, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH PATIENT RESULTS FOR ION SELECTIVE ELECTRODE (ISE), INCLUDING SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), 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 DEMOGRAPHICS. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR ONE (1) PATIENT SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17634066 ↗
• MalfunctionAug 23, 2023High Test Results; High Test Results

  ON (B)(6) 2023, THE CUSTOMER REPORTED OBTAINING HIGH GLUCOSE (GLU) PATIENT RESULTS FOR FIFTY-FIVE (55) PATIENTS ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPEATED THE PATIENT SAMPLES AND OBTAINED RESULTS CONSIDERED CORRECT. THE CUSTOMER REPORTED THE INITIAL HIGH RESULTS OUT OF THE LABORATORY; HOWEVER, THEY WERE AMENDED LATER. THERE WAS NO CHANGE TO TREATMENT, INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENTS DEMOGRAPHICS. THE CUSTOMER PROVIDED THE DATA FOR 55 PATIENTS IN THE ATTACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607351 ↗
• MalfunctionAug 3, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUSLY HIGH 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 THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455583 ↗
• MalfunctionJul 17, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF FALSE LOW ISE (ION SELECTIVE ELECTRODE) PATIENT RESULTS ON THEIR DXC 700 AU CHEMISTRY ANALYZER. ALL ABNORMAL PATIENT RESULTS WERE CHECKED ON ANOTHER ANALYSER AND NO ABNORMAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE NUMBER OF PATIENTS AFFECTED IS UNKNOWN AS THE CUSTOMER DID NOT PROVIDE DATA OR PATIENT DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336148 ↗
• MalfunctionJan 11, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF LOW PATIENT RESULTS FOR SODIUM (NA) ON THEIR DXC 700 AU CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER REPEATED THE PATIENT SAMPLE WITH RESULTS HIGHER. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS. CUSTOMER PROVIDED THE RESULTS FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135610 ↗
• MalfunctionJun 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS PATIENT RESULTS FOR SODIUM (NA), POTASSIUM (K), CREATININE (CRE) AND CHOLESTEROL (CHOL) ON THEIR DXC 700 AU CHEMISTRY ANALYZER. THE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF CHANGE TO TREATMENT, INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS OR DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760858 ↗
• MalfunctionApr 6, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF FALSE 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 THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027036 ↗