COULTER AcT diff 12, diff 16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15099590264734), received between Oct 7, 2016 and Jul 8, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2021Priming Problem; Priming Problem

  THE CUSTOMER REPORTED THAT THE RESULTS GENERATED ON THEIR ACT DIFF HEMATOLOGY INSTRUMENT FOR TWO PATIENT SAMPLES WERE ERRONEOUSLY HIGH. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. ONE OF THE PATIENTS WERE INITIALLY SENT TO THE HOSPITAL EMERGENCY ROOM BUT THE RECOMMENDATION WAS REVERSED ONCE THE CUSTOMER IDENTIFIED AN INSTRUMENT PROBLEM. NO OTHER IMPACT TO PATIENT OR TREATMENT WAS REPORTED. ADDITIONAL INFORMATION ABOUT THE IMPACTED PATIENT WAS REQUESTED. THE CUSTOMER TECHNICAL SPECIALIST (CTS) ATTEMPTED TO GET THE DETAILS REGARDING THE PATIENT WHO WENT TO ER BUT WAS UNABLE TO GET ADDITIONAL INFORMATION FROM THE CUSTOMER..

  Patient problems: Insufficient Information

  MAUDE report 12140601 ↗
• MalfunctionOct 27, 2016Fluid/Blood Leak; Missing Test Results; Fluid/Blood Leak; Missing Test Results

  THE CUSTOMER REPORTED AN UNCONTAINED FLUID LEAK APPROXIMATELY 1ML IN VOLUME AND NORMAL AND HIGH CONTROL FAILURES ON THEIR COULTER AC·T DIFF ANALYZER. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT, GLOVES AND EYE PROTECTION AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6062101 ↗
• MalfunctionOct 7, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED LESS THAN 1 ML OF UNCONTAINED FLUID LEAKED FROM THE PROBE IN A COULTER AC T DIFF ANALYZER ONTO THE COUNTER DURING NORMAL INSTRUMENT OPERATION. THERE WERE VACUUM ERROR MESSAGES REPORTED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT, GOGGLES AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS.

  Patient problems: Not Applicable

  MAUDE report 6012497 ↗
• MalfunctionOct 7, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A FEW DROPS OF UNCONTAINED FLUID LEAKED FROM WHITE BLOOD CELL (WBC) BATH OVERFLOW IN A COULTER AC T DIFF ANALYZER DURING NORMAL INSTRUMENT OPERATION. THERE WERE NO ERROR MESSAGES REPORTED BY THE CUSTOMER AT THE TIME OF THE EVENT. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO PATIENT RESULTS AND CONTROLS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES.

  Patient problems: Not Applicable

  MAUDE report 6012023 ↗