Dade® Actin® FSL Activated PTT Reagent 10445713Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842768003875), received between Oct 5, 2017 and Jan 19, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K863594); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A CUSTOMER SCRAPED THEIR FINGER WHILE OPENING A VIAL OF DADE ACTIN FSL ACTIVATED PTT REAGENT. THE CUSTOMER DISINFECTED AND BANDAGED THE WOUND. NO MEDICAL INTERVENTION WAS REQUIRED BEYOND FIRST AID. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195983 ↗
• MalfunctionNov 24, 2020High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON SIX PATIENT SAMPLES ON A SYSMEX CA-660 SYSTEM USING DADE ACTIN FSL ACTIVATED PTT REAGENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REFRIGERATED AND RERUN THE FOLLOWING DAY FOR APTT, AS THE CUSTOMER WAS QUESTIONING THE RESULTS. THE REPEATED SAMPLES RECOVERED LOWER. THESE REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896329 ↗
• MalfunctionFeb 13, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) SAMPLE RESULT WAS OBTAINED ON ONE PATIENT USING A SYSMEX CA-1500 SYSTEM AND THE DADE ACTIN FSL ACTIVATED PTT REAGENT. THE SAMPLE WAS AUTO REPEATED AND THE RESULT WAS SIMILAR. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). APPROXIMATELY THREE HOURS LATER, THE SAMPLE WAS MIXED, CHECKED FOR CLOTS, CENTRIFUGED AGAIN AND RETESTED RESULTING LOWER. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). A SECOND SAMPLE WAS DRAWN FROM THE PATIENT AND THE RESULT AGREED WITH THE INITIAL REPORTED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED APTT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707654 ↗
• MalfunctionJul 6, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MULTIPLE DISCORDANT PROTHROMBIN TIME (PT) PATIENT SAMPLE RESULTS WERE GENERATED ON A SYSMEX CA-620 SYSTEM (SERIAL NUMBER (B)(4)) AND REPORTED TO PHYSICIANS USING DADE INNOVIN LOT 539388 WHEN QUALITY CONTROL (QC) FOR PT WAS OUT OF RANGE. SOME PATIENT SAMPLES WERE RUN FOR ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) USING DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 556912. ON THE FOLLOWING DAY ((B)(6) 2018), ALL PATIENT SAMPLES WERE RETESTED AT AN ALTERNATE LABORATORY ON A SYSMEX CS-2500 SYSTEM, USING DADE INNOVIN LOT 549704 AND DADE ACTIN FSL ACTIVATED PTT REAGENT LOT 556904. NO CORRECTED REPORTS WERE ISSUED TO PHYSICIANS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCES IN APTT RESULTS BETWEEN THE TWO LABORATORIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7666615 ↗
• MalfunctionNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE TUBE ON THE SYSMEX CA-560 SYSTEM. THIS DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN, WHO DID NOT QUESTION THE RESULT. THE SAME SAMPLE WAS TRANSFERRED TO A SAMPLE CUP AND RERUN ON THE SAME SYSTEM, RESULTING LOWER. THE PATIENT'S BLOOD WAS REDRAWN AND RUN IN A PRIMARY TUBE AND IN A SAMPLE CUP ON THE SAME SYSTEM, RESULTING LOWER THAN THE INITIAL RESULT. THE APTT RESULT OBTAINED ON THE REDRAWN SAMPLE TUBE WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7068659 ↗
• MalfunctionOct 5, 2017High Test Results; High Test Results

  A POTENTIALLY DISCORDANT ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE SYSMEX CA-620 SYSTEM. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME PATIENT SAMPLE WAS RERUN ON THE SAME SYSTEM, RESULTING LOWER. THE REPEATED RESULT WAS NOT REPORTED TO THE PHYSICIAN AND THE CORRECT RESULT FOR THIS PATIENT IS UNKNOWN. PRIOR TO RUNNING THE PATIENT SAMPLE, THE CUSTOMER EXPERIENCED ISSUES WITH THE INTERNAL QUALITY CONTROLS. THE CUSTOMER INDICATED THAT INTERNAL QUALITY CONTROLS RECOVERED WITHIN RANGE ONCE SHE RAN INTERNAL QUALITY CONTROLS IN A CONICAL CUP, AS OPPOSE TO RUNNING THEM IN SAMPLE TUBES. THE CUSTOMER INDICATED THAT SHE RAN THE PATIENT SAMPLES AFTER THE INTERNAL QUALITY CONTROL RECOVERED WITHIN EXPECTED RANGES. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POTENTIALLY DISCORDANT APTT RESULTS OBTAINED ON THIS PATIENT SAMPLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6916861 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K863594. One submission often covers many models, so check the product and lot details in each record.

• Z-1073-2013 · Mar 11, 2013 · Terminated
  Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
• Z-1043-2012 · Dec 19, 2011 · Terminated
  Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit brain phosphatides with plasma activator. An activated partial thromboplastin reagent wit