AU B96695Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14987666542996), received between Nov 20, 2020 and Dec 3, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF ERRONEOUS LOW ION-SELECTIVE ELECTROLYTES (ISE), SPECIFICALLY 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 STATED SODIUM RESULTS WERE LESS THAN 130 MMOL/L. THE CUSTOMER DID NOT PROVIDE PATIENT DATA PRINTOUTS OR DEMOGRAPHICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835751 ↗
• MalfunctionMar 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER REPORTED THE GENERATION OF ERRONEOUS ION-SELECTIVE ELECTROLYTES (ISE) RESULTS FOR EIGHT (8) PATIENT SAMPLES ON THEIR AU680 CHEMISTRY ANALYZER. 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 13931430 ↗
• MalfunctionNov 20, 2020Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE GENERATION OF AN ERRONEOUS LOW SODIUM (NA) PATIENT RESULT ON THEIR AU680 INSTRUMENT. THE RESULT WAS NOT REPORTED OUT 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. THE CUSTOMER VERBALLY PROVIDED EXAMPLES OF THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10877884 ↗