COULTER AcT 5diff (REF 6605641)Recalls & reported problems
Beckman Coulter, Inc. · COULTER AcT 5diff Cap Pierce Hematology Analyzer · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590579005), received between Dec 14, 2021 and Dec 14, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THE TRAVERSE ON THE ACT 5 DIFF CP HEMATOLOGY ANALYZER WAS NOT REACHING HOME. HIGH UNFLAGGED PLATELET (PLT) VALUES AND PLT VOTE OUTS WERE ALSO RECOVERED FOR PATIENT SAMPLES. ERRONEOUS RESULTS GENERATED FROM THE ANALYZER, HOWEVER, ERRONEOUS RESULTS REPORTED OUT OF THE LAB. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. INSTRUMENT DATA OF THREE (3) PATIENT SAMPLES WERE PROVIDED FOR REVIEW. ON (B)(6) 2021, PATIENT 1 SAMPLE WAS RUN IN CBC MODE ON THE ACT 5 DIFF CP RECOVERING HIGH PLT RESULTS OF 724 X 103 CELLS/L WITH NO PLT SPECIFIC INSTRUMENT SUSPECT MESSAGES. THE PATIENT¿S SAMPLE WAS RERUN (X3) ON THE SAME DAY RECOVERING LOWER PLT RESULTS OF 192, 123 AND 105 X 103 CELLS/L RESPECTIVELY. THE CUSTOMER PERFORMED SHUTDOWN, STARTUP AND QC WHICH RECOVERED WITHIN THE EXPECTED RANGE. THE PATIENT¿S SAMPLE WAS RERAN RECOVERING A PLT RESULT OF 105 X 103 CELLS/L WHICH WAS CONSIDERED CORRECT. ON (B)(6) 2021, PATIENT 2 AND PATIENT 3 SAMPLES WERE RUN ON THE ACT 5 DIFF CP INSTRUMENT RECOVERING RESULTS WITH PLT VOTE OUTS, DIFF ¿R¿ FLAGS, PLT INTERPRETATION NOT POSSIBLE, NRBC AND PLT AGGREGATES INSTRUMENT INTERPRETIVE MESSAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13006904 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.