COULTER AcT 5diff (REF 175356)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15099590576479), received between Jul 23, 2018 and Apr 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

• MalfunctionApr 28, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE FIELD SERVICE ENGINEER (FSE) REPORTED PLATELET (PLT) BACKGROUND AND CONTROL SAMPLES WERE VERY HIGH ON THE CUSTOMER¿S ACT 5DIFF AL ANALYZER AFTER CUSTOMER INSTALLED USED DILUENT REAGENT. THERE WAS NO REPORT OF AN ADVERSE EVENT. THERE WAS NO REPORT OF ERRONEOUS PATIENT RESULTS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE FSE PROVIDED ONE EXAMPLE SHOWING THE REPORTED ELEVATED PLT RESULT ISSUE ON A PATIENT SAMPLE AND THE INSTRUMENT HAD FAILED STARTUP FOR PLT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14247004 ↗
• MalfunctionSep 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INITIALLY REPORTED H&H WAS NOT MATCHING FOR PATIENT SAMPLES RUN ON THE ACT5DIFF AL INSTRUMENT. THE CUSTOMER ALSO STATED A GRINDING NOISED WAS OBSERVED COMING FROM THE INSTRUMENT. THE FIELD SERVICE ENGINEER STATED THAT UPON ARRIVAL HE FOUND THE INSTRUMENT OUT OF USE AND REVIEWED QUESTIONABLE PATIENT SAMPLES WITH EXTREMELY HIGH RBC AND PLT VALUES. THERE WERE A TOTAL OF FOUR ERRONEOUS PATIENT RESULTS GENERATED AND ONE RESULT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF AN ADVERSE EVENT OR IMPACT TO PATIENT TREATMENT. INSTRUMENT DATA OF THE ERRONEOUS RESULTS HAS NOT BEEN PROVIDED FOR REVIEW, AS A RESULT INSTRUMENT FLAGGING COULD NOT BE ASSESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543816 ↗
• MalfunctionOct 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PLATELETS ERRONEOUS RESULTS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159319 ↗
• MalfunctionJul 23, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER WAS GENERATING ERRONEOUS HIGH PLATELET (PLT) RESULTS. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PATIENT AND CONTROL DATA WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Test Result

  MAUDE report 7712626 ↗