ACL TOP 300 CTS 00000280060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950556916), received between Jun 11, 2020 and Jun 11, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CUSTOMER WAS PERFORMING REAGENT PROBE COORDINATE ADJUSTMENT ON THE ACL TOP 300 CTS ANALYZER. THE USER NOTICED THE CTS FOOT WAS DIRTY AND PRECEDED TO CLEAN THE CTS FOOT. WHILE ATTEMPTING TO CLEAN THE CTS FOOT, THE USER'S HAND WAS CUT. CUSTOMER WAS WEARING GLOVES AT TIME OF INCIDENT. SHE WENT TO EMERGENCY ROOM PER LAB POLICY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10145652 ↗