Dade® Actin® Activated Cephaloplastin Reagent 10445711Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00842768003851), received between Aug 11, 2017 and Jan 18, 2021 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K760318); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES BETWEEN (B)(6) 2020 AND (B)(6) 2020 ON A BCS XP SYSTEM USING DADE ACTIN ACTIVATED CEPHALOSTATIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR APTT ON THE SAME BCS XP SYSTEM USING PATHROMTIN SL REAGENT, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187913 ↗
• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES BETWEEN (B)(6) 2020 AND (B)(6) 2020 ON A BCS XP SYSTEM USING DADE ACTIN ACTIVATED CEPHALOSTATIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR APTT ON THE SAME BCS XP SYSTEM USING PATHROMTIN SL REAGENT, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187905 ↗
• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES BETWEEN (B)(6) 2020 AND (B)(6) 2020 ON A BCS XP SYSTEM USING DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR APTT ON THE SAME BCS XP SYSTEM USING PATHROMTIN SL REAGENT, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187896 ↗
• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES BETWEEN (B)(6) 2020 ON A BCS XP SYSTEM USING DADE ACTING ACTIVATED CEPHALOPLASTIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR APTT ON THE SAME BCS XP SYSTEM USING PATHROMTIN SL REAGENT, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187895 ↗
• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES BETWEEN (B)(6) 2020 AND (B)(6) 2020 ON A BCS XP SYSTEM USING DADE ACTIN ACTIVATED CEPHALOSTATIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR APTT ON THE SAME BCS XP SYSTEM USING PATHROMTIN SL REAGENT, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187890 ↗
• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES BETWEEN (B)(6) 2020 ON A BCS XP SYSTEM USING DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR APTT ON THE SAME BCS XP SYSTEM USING PATHROMTIN SL REAGENT, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187881 ↗
• MalfunctionJan 18, 2021Low Test Results; Low Test Results

  DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES BETWEEN (B)(6) 2020 AND (B)(6) 2020 ON A BCS XP SYSTEM USING DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED FOR APTT ON THE SAME BCS XP SYSTEM USING PATHROMTIN SL REAGENT, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187870 ↗
• MalfunctionAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM. IT IS UNKNOWN WHETHER THESE RESULTS WERE REPORTED TO THE PHYSICIAN AND IT IS UNKNOWN WHETHER THESE RESULTS WERE DISCORDANT. ON (B)(6) 2017, DIFFERENT APTT RESULTS FROM OTHER SAMPLES OF THE SAME PATIENT WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER INDICATED THAT THE RESULTS OBTAINED ON (B)(6) 2017 WERE THE CORRECT RESULTS FOR THIS PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE APTT RESULTS REPORTED TO THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6789784 ↗
• MalfunctionAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO DISCORDANT, FALSELY LOW ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CS-5100 SYSTEM. ONE RESULT WAS OBTAINED BY MIXING A TEST IN A ONE-TO-ONE DILUTION WITH THE PATIENT SAMPLE AND THE OTHER WAS OBTAINED BY ADDING POLYBRENE. THESE RESULTS WERE REPORTED TO THE PHYSICIAN AND IT IS UNKNOWN WHETHER THE PHYSICIAN QUESTIONED THESE RESULTS. ON (B)(6) 2017, CORRECT APTT RESULTS FROM OTHER SAMPLES OF THE SAME PATIENT WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW APTT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6789762 ↗
• MalfunctionAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MULTIPLE FLAGGED NON-NUMERICAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON THREE SAMPLES FROM THE SAME PATIENT ON THE SYSMEX CS-5100 SYSTEM. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. ONE PATIENT SAMPLE WAS RE-RUN ON AN ALTERNATE SYSMEX CS-5100 SYSTEM, RESULTING IN ANOTHER NON-NUMERICAL RESULT. THE CUSTOMER INCORRECTLY REPORTED THE TIME (IN SECONDS) THAT CORRESPONDED TO 50% OF THE COAGULATION CURVE TO THE PHYSICIAN. THE PHYSICIAN MISINTERPRETED THE SYSTEM'S EARLY REACTION ERROR AS SHORT COAGULATION TIME. THE PATIENT BLOOD WAS REDRAWN ON THE NEXT DAY AND RUN ON THE INITIAL SYSTEM. AN APTT RESULT WITH NO FLAGS WAS OBTAINED AND PROVIDED TO THE PHYSICIAN. ON THE FOLLOWING DAY, THE PATIENT BLOOD WAS REDRAWN AGAIN AND RUN ON THE INITIAL SYSTEM. ANOTHER CORRECTED APTT RESULT WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE APTT RESULT THAT WAS INCORRECTLY REPORTED TO THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6789759 ↗
• MalfunctionAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NON-NUMERICAL FLAGGED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE SYSMEX CS-5100 SYSTEM. THE CUSTOMER INCORRECTLY REPORTED 2 OF 3 NON-NUMERICAL APTT RESULTS TO THE PHYSICIAN BY REPORTING THE TIME (IN SECONDS) THAT CORRESPONDED TO 50% OF THE COAGULATION CURVE. ONE PATIENT SAMPLE WAS RE-RUN ON THE SAME SYSTEM TWICE, RESULTING IN TWO APTT RESULTS. A DISCORDANT, FALSELY LOW APTT RESULT, OBTAINED BY ADDING POLYBRENE, AND A CORRECT APTT RESULT WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN MISINTERPRETED THE SYSTEM'S EARLY REACTION ERROR AS SHORT COAGULATION TIME. ON THE PREVIOUS DAY, THE CUSTOMER REPORTED A CORRECT APTT RESULT TO THE PHYSICIAN THAT WAS OBTAINED ON ANOTHER SAMPLE FROM THE SAME PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE APTT RESULTS THAT WERE REPORTED TO THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6789758 ↗
• MalfunctionAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NON-NUMERICAL FLAGGED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON THE SYSMEX CS-5100 SYSTEM. THE CUSTOMER INCORRECTLY REPORTED THE TIME (IN SECONDS) THAT CORRESPONDED TO 50% OF THE COAGULATION CURVE FOR ONE SAMPLE TO THE PHYSICIAN. THE PATIENT BLOOD WAS REDRAWN TWICE AND RUN ON THE SAME SYSTEM, RESULTING IN TWO APTT RESULTS. A DISCORDANT, FALSELY LOW APTT RESULT AND A CORRECT APTT RESULT WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN MISINTERPRETED THE SYSTEM'S EARLY REACTION ERROR AS SHORT COAGULATION TIME. THE PATIENT BLOOD WAS REDRAWN AGAIN ON THE NEXT DAY AND RUN ON THE SAME SYSTEM. AN APTT RESULT WITHOUT FLAG(S) WAS OBTAINED AND PROVIDED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW APTT RESULTS REPORTED TO THE PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6789733 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K760318. One submission often covers many models, so check the product and lot details in each record.

• Z-1703-2015 · Mar 25, 2015 · Terminated
  Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for use in the determination of the activated partial thromboplastin time (APTT) and