Dade® Actin® FS Activated PTT Reagent 10445712Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842768003868), received between Mar 25, 2021 and Jul 24, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K811589); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT NORMAL APTT (SEC) RESULTS COMPARED TO AN ALTERNATE METHOD AS PATIENT IS TREATED WITH UNFRACTIONATED HEPARIN. THE PATIENT SAMPLE WAS MEASURED WITH DADE ACTIN FS ACTIVATED PTT REAGENT ON THE CA-660 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584921 ↗
• MalfunctionJul 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT NORMAL APTT (SEC) RESULTS COMPARED TO AN ALTERNATE METHOD AS PATIENT IS TREATED WITH UNFRACTIONATED HEPARIN. THE PATIENT SAMPLE WAS MEASURED WITH DADE ACTIN FS ACTIVATED PTT REAGENT ON THE CA-660 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584919 ↗
• MalfunctionJul 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT NORMAL APTT (SEC) RESULTS COMPARED TO AN ALTERNATE METHOD AS PATIENT IS TREATED WITH UNFRACTIONATED HEPARIN. THE PATIENT SAMPLE WAS MEASURED WITH DADE ACTIN FS ACTIVATED PTT REAGENT ON THE CA-660 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584913 ↗
• MalfunctionJul 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT NORMAL APTT (SEC) RESULTS COMPARED TO THE CLINICAL PICTURE AS PATIENT IS TREATED WITH UNFRACTIONATED HEPARIN. THE PATIENT SAMPLE WAS MEASURED WITH DADE ACTIN FS ACTIVATED PTT REAGENT ON THE CA-660 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584911 ↗
• MalfunctionJul 24, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT NORMAL APTT (SEC) RESULTS COMPARED TO THE CLINICAL PICTURE AS PATIENT IS TREATED WITH UNFRACTIONATED HEPARIN. THE PATIENT SAMPLE WAS MEASURED WITH DADE ACTIN FS ACTIVATED PTT REAGENT ON THE CA-660 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584858 ↗
• MalfunctionJul 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT NORMAL APTT (SEC) RESULTS COMPARED TO AN ALTERNATE METHOD AS PATIENT IS TREATED WITH UNFRACTIONATED HEPARIN. THE PATIENT SAMPLE WAS MEASURED WITH DADE ACTIN FS ACTIVATED PTT REAGENT ON THE CA-660 INSTRUMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563789 ↗
• MalfunctionMar 25, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER FAILED AN AMERICAN PROFICIENCY INSTITUTE (API) SURVEY FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT). THE CUSTOMER REALIZED THAT ALTHOUGH THEIR SYSMEX CA-660 SYSTEM WAS SET UP TO RUN DADE ACTIN FSL ACTIVATED PTT REAGENT, THEY WERE INCORRECTLY USING DADE ACTIN FS ACTIVATED PTT REAGENT. THE CUSTOMER HAS INCORRECTLY USED DADE ACTIN FS ACTIVATED PTT REAGENT SINCE JANUARY 2020. NO APTT PATIENT RESULTS HAVE BEEN QUESTIONED BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570107 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K811589. One submission often covers many models, so check the product and lot details in each record.

• Z-0304-06 · Sep 23, 2005 · Terminated
  Dade Actin FS Activated PTT Reagent. Reagent and Control Partial Thromboplastin Time. Catalog number B4218-100