ACL TOP 550 CTS 00000280045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08426950729242), received between Mar 1, 2019 and Nov 6, 2024 — classified as 3 injuries.

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

2 FDA recall records name this device's identifier, 2 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. Jul 13, 2023Class IIOpen, Classified

   Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result

   Z-2578-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Use of Device Problem; Use of Device Problem

  A COMPLAINT WAS FILED ON OCTOBER 25, 2024 REGARDING ACL TOP 550 CTS SN (B)(6) INDICATING USER ACCIDENTALLY PUNCTURED HIS FINGER ON PROBE WHILE TRYING TO UNLOCK IT. COMPLAINT MENTIONED THAT A COLLEAGUE PLACED A CLOSED TUBE IN THE WRONG RACK (WITHOUT A CAP) AND THE NEEDLE GOT STUCK, AND THE USER PRICKED HIS FINGER WHEN UNLATCHING THE PERFORATOR AND THE TUBE. THERE WAS NO KNOWN ADVERSE EFFECT FROM THE PUNCTURE.

  Patient problems: Abrasion

  MAUDE report 20622329 ↗
• InjuryJul 21, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN ACL TOP 550 CTS INSTRUMENT OPERATOR DEVELOPED A LACERATION RESULTING IN BLEEDING ON THE FINGER OF HER GLOVED HAND. THIS INCIDENT OCCURRED WHILE TROUBLESHOOTING TO CLEAN AND REMOVE CUVETTES FROM THE WASTE AREA OF THE INSTRUMENT. THE STAFF MEMBER RECEIVED MEDICAL ATTENTION IN THE EMERGENCY DEPARTMENT AT THE HOSPITAL AND FILED AN INCIDENT REPORT. NO STITCHES WERE NECESSARY. THE STAFF MEMBER WAS PLACED ON MEDICATION FOR (B)(6) PROPHYLAXIS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10303571 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT THEIR ACL TOP 550 CTS GENERATED ERRONEOUS APTT RESULTS USING HEMOSIL SYNTHASIL. THREE PATIENTS WERE ADMINISTERED AN INCREASED DOSE OF HEPARIN BASED ON THE ERRONEOUS APTT RESULTS. THE APTT RESULTS WERE LATER CORRECTED AND THE HEPARIN DOSES WERE ADJUSTED AS APPROPRIATE. AFTER THE ADDITIONAL DOSE OF HEPARIN, THE PATIENTS WERE MONITORED AND THERE WERE NO COMPLICATIONS FROM THE ADDITIONAL HEPARIN ADMINISTERED.

  Patient problems: Therapeutic Response, Increased

  MAUDE report 8383931 ↗