Dade® Actin® FS Activated PTT Reagent 10445710Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842768003844), received between Jan 19, 2018 and May 29, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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.

• MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED FACTOR VIII (F VIII) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH ACTIN FS ON THE CS-5100 INSTRUMENT COMPARED TO ALTERNATE METHOD. NO RESULT WAS REPORTED. IT IS UNCLEAR WHICH IS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INCREASED F VIII RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329237 ↗
• MalfunctionMay 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT INCREASED FACTOR VIII (F VIII) RESULTS OBTAINED ON ONE PATIENT MEASURED WITH ACTIN FS ON THE CS-5100 INSTRUMENT COMPARED TO ALTERNATE METHOD. BOTH, CS-5100 AND ALTERNATE METHOD RESULTS WERE REPORTED TO THE PHYSICIAN, BUT IT IS UNCLEAR WHICH IS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT INCREASED F VIII RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25329178 ↗
• MalfunctionJun 13, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A SYSMEX CS-5100 SYSTEM USING DADE ACTIN FS ACTIVATED PTT REAGENT (LOT#: 538551). THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE SAME SAMPLE WAS SENT TO A DIFFERENT LAB AND WAS RUN FOR APTT ON A NON-SIEMENS INSTRUMENT WITH UNKNOWN REAGENT, RESULTING IN A LOWER APTT RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). DUE TO THE DISCORDANT FALSELY ELEVATED APTT RESULT, VITAMIN K REVERSAL THERAPY WAS STARTED ON THE PATIENT; HOWEVER, THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THE VITAMIN K REVERSAL THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8696828 ↗
• MalfunctionJun 13, 2019High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES FROM THE SAME PATIENT ON A SYSMEX CS-5100 SYSTEM USING DADE ACTIN FS ACTIVATED PTT REAGENT (LOT#: 538551). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE FOLLOWING DAY, A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS RUN FOR APTT ON A NON-SIEMENS INSTRUMENT WITH UNKNOWN REAGENT, RESULTING IN A LOWER APTT RESULT. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). DUE TO THE DISCORDANT FALSELY ELEVATED APTT RESULTS, VITAMIN K REVERSAL THERAPY WAS STARTED ON THE PATIENT; HOWEVER, THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THE VITAMIN K REVERSAL THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8696730 ↗
• MalfunctionJan 30, 2018High Test Results; High Test Results

  FALSELY HIGH, FLAGGED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) PATIENT RESULTS ON MULTIPLE PATIENTS WERE GENERATED ON A SYSMEX CS-5100 ANALYZER AFTER QUALITY CONTROL (QC) FAILURE. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLES WERE REPEATED ON A DIFFERENT SYSMEX CS-5100 (WITH ACCEPTABLE QC) AND LOWER APTT PATIENT RESULTS WERE GENERATED. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED OUT TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH, FLAGGED PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228075 ↗
• MalfunctionJan 30, 2018High Test Results; High Test Results

  FALSELY HIGH, FLAGGED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) PATIENT RESULTS ON MULTIPLE PATIENTS WERE GENERATED ON A SYSMEX CS-5100 ANALYZER AFTER QUALITY CONTROL (QC) FAILURE. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME PATIENT SAMPLES WERE REPEATED ON A DIFFERENT SYSMEX CS-5100 (WITH ACCEPTABLE QC) AND LOWER APTT PATIENT RESULTS WERE GENERATED. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED OUT TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH, FLAGGED PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7228071 ↗
• MalfunctionJan 19, 2018High Test Results; High Test Results

  DISCORDANT HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT), PROTHROMBIN TIME (PT), INTERNATIONAL NORMALIZED RATIO (INR), AND DERIVED FIBRINOGEN (DER FIB) PATIENT RESULTS ON ONE (1) PATIENT SAMPLE WERE GENERATED ON A SYSMEX CS-5100 ANALYZER (SN (B)(4)). THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN AS THEY DID NOT MEET THE CLINICAL HISTORY OF THE PATIENT. THE SAME PATIENT SAMPLE WAS REPEATED ON A DIFFERENT SYSMEX CS-5100 (SN (B)(4)) AND LOWER APTT, PT, INR, AND DER FIB PATIENT RESULTS WERE GENERATED. THESE RESULTS WERE REPORTED TO THE PHYSICIAN. ALL RESULTS WERE RUN ON THE SAME DAY ((B)(6) 2017) ON THE SAME PATIENT SAMPLE. THE PT /INR /DER FIB PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THROMBOREL S REAGENT AND APTT PATIENT RESULTS (INITIAL AND REPEAT) WERE GENERATED USING THE DADE ACTIN FS ACTIVATED PARTIAL THROMBOPLASTIN TIME (PTT) REAGENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT HIGH APTT, PT, INR, AND DER FIB PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7207695 ↗

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