Acquity 725000662IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816776020315), received between Mar 3, 2022 and Mar 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  CUSTOMER REPORTS THAT THE WATERS 3777C SAMPLE MANAGER INJECTED A SAMPLE FROM THE INCORRECT VIAL LOCATION. THIS OCCURRED WHEN THE CUSTOMER PAUSED AN ACTIVE BATCH OF PATIENT SAMPLES IN ORDER TO ADD SOME PRIORITY SAMPLES, WHICH WERE ADDITIONAL CONTROLS MISSING FROM THE ORIGINAL BATCH. AT THE TIME THE LIST WAS PAUSED THE NEXT SAMPLE IN THE BATCH HAD ALREADY BEEN DRAWN INTO THE INJECTOR USING THE SINGLE SAMPLE OVERLAP FUNCTION. WHEN RESTARTING THE RUN, THIS PRE-DRAWN SAMPLE WAS INJECTED BUT RECORDED IN THE DATA FILE FOR THE FIRST OF THE PRIORITY SAMPLES. AFTER THE PRIORITY SAMPLES WERE RUN THE SAMPLE LIST RESUMED AND THE PRE-DRAWN SAMPLE WAS INJECTED AGAIN. IN THIS CASE, THE INCORRECTLY INJECTED SAMPLE WAS A CONTROL AND NOT A PATIENT SAMPLE. THERE IS NO ALLEGED MISREPORTING OF PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663756 ↗