COULTER AcT 5diff (REF 6605581)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590576462), received between Oct 20, 2018 and Oct 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K992511); they may or may not involve this specific model.

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

• MalfunctionOct 20, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER WAS EXPERIENCING HIGH PLATELET COUNTS. IT COULD NOT BE CONFIRMED IF IT WAS CONTROLS OR PATIENT SAMPLES THAT WERE AFFECTED. THE CUSTOMER DID NOT PROVIDE PATIENT OR CONTROL DATA. THERE WAS NO REPORT OF CHANGE OF PATIENT TREATMENT OR AFFECT TO THE PATIENT.

  Patient problems: Test Result

  MAUDE report 7988190 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992511. One submission often covers many models, so check the product and lot details in each record.

• Z-0039-04 · Sep 8, 2003 · Terminated
  Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604