ACL TOP 500 CTS 00000280040Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08426950453499), received between Sep 11, 2017 and Oct 13, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 22, 2022Class IIOpen, Classified

   Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in the same run with both HemosIL Liquid Antithrombin and HemosIL Q.F.A. Thrombin (Bovine), specific to instrument models that utilize a single reagent probe

   Z-1014-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2023Use of Device Problem; Use of Device Problem

  CUSTOMER INJURED FINGER WHILE REMOVING SAMPLE TUBE FROM CTS SAMPLE PROBE WHILE TROUBLESHOOTING. CUSTOMER WAS WEARING GLOVES AT THE TIME. CUSTOMER WENT TO OCCUPATIONAL HEALTH TO BE EVALUATED.

  Patient problems: Abrasion

  MAUDE report 17934001 ↗
• InjuryMay 17, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER WAS INJURED DURING MAINTENANCE PROCEDURE "CLEAN DEEP WASH AND CLEAN CUP AREA". THE CUSTOMER CLEANED THE SAMPLE CUP AREA AND AFTER THIS OPERATION TURNED UP THE FOOTER AND WAS INJURED WITH THE PIERCER. THE CUSTOMER WAS WEARING GLOVES. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE PUNCTURE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16948092 ↗
• InjurySep 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. FOUR PATIENTS HAD RESULTS THAT WERE CLINICALLY SIGNIFICANT AND NEEDED TO BE CORRECTED. ONE PATIENT WAS ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THE ERRONEOUS APTT RESULT. THE APTT RESULT WAS LATER CORRECTED AND THE HEPARIN DOSE WAS ADJUSTED AS APPROPRIATE. THERE WERE NO KNOWN COMPLICATIONS TO THE PATIENT FROM THE ADDITIONAL HEPARIN ADMINISTERED.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 8956671 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. FOUR PATIENTS WERE ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THE ERRONEOUS APTT RESULTS. AFTER THE ADDITIONAL DOSE OF HEPARIN, THE PATIENTS WERE MONITORED WITH NO FURTHER REPORTS OF CLINICAL IMPLICATIONS.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 8225762 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS GENERATED AN ERRONEOUS APTT RESULT (36.9 SECONDS) USING HEMOSIL SYNTHASIL. A PATIENT WAS ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THIS ERRONEOUS APTT RESULT. SUBSEQUENTLY, ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT (APPROXIMATELY 3 HOURS LATER) AND IT REPORTED AN APTT RESULT OF > 200. THE HEPARIN ADMINISTRATION WAS STOPPED AND THE CUSTOMER INDICATED THAT THE PATIENT'S APTT RESULT WAS BROUGHT BACK INTO THE THERAPEUTIC RANGE. THERE WERE NO FURTHER REPORTS OF CLINICAL IMPLICATIONS FOR THE PATIENT.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 8024101 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT RESULTS FOR 6 PATIENTS USING HEMOSIL SYNTHASIL. ALL 6 PATIENT SAMPLE RESULTS WERE RE-RUN AND CORRECTED. ONE PATIENT (CH) WAS ADMINISTERED A BOLUS OF HEPARIN. CH DEVELOPED A SUPERFICIAL RIGHT GROIN HEMATOMA. THE CUSTOMER WAS UNABLE TO DETERMINE IF THIS WAS A RESULT OF THE BOLUS OF HEPARIN.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 7038808 ↗
• InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. SIX PATIENT SAMPLES GENERATED ERRONEOUS RESULTS. ONE PATIENT WAS ADMINISTERED AN UNNECESSARY BOLUS OF HEPARIN DUE TO THE APTT RESULT BEING LOWER THAN EXPECTED. ALL SIX SAMPLES WERE SUBSEQUENTLY CORRECTED AND THERE WERE NO REPORTED SERIOUS ADVERSE EVENTS.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 6885953 ↗
• InjurySep 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THEIR ACL TOP 500 CTS REPORTED ERRONEOUS APTT PATIENT RESULTS USING HEMOSIL SYNTHASIL. OF THE 41 AFFECTED PATIENT SAMPLES, FIFTEEN TO TWENTY PATIENTS WERE ADMINISTERED UNNECESSARY BOLUSES OF HEPARIN DUE TO RESULTS BEING LOWER THAN EXPECTED. ALL FORTY-ONE SAMPLES WERE SUBSEQUENTLY CORRECTED AND THERE WERE NO REPORTED SERIOUS ADVERSE EVENTS.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 6856196 ↗