ACL TOP 350 CTS 00000280065Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950784081), received between Sep 6, 2022 and Sep 6, 2022 — classified as 1 injury.

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

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

• InjurySep 6, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN ACL TOP 350 CTS INSTRUMENT OPERATOR RECEIVED A SCRATCH ON THE THUMB OF HER GLOVED HAND WHILE TROUBLESHOOTING TO REMOVE A STUCK SAMPLE PROBE. A SAMPLE TUBE WAS LOADED INTO AN INCORRECT SAMPLE RACK, THUS RESULTING IN THE SAMPLE PROBE BEING STUCK IN THE SAMPLE TUBE. THE TECH SCRATCHED HER THUMB ON THE REAGENT PROBE WHILE ATTEMPTING TO REMOVE THE STUCK SAMPLE PROBE. THE STAFF MEMBER RECEIVED A BAND AID AND ANTI-VIRUS/ANTIBIOTIC TREATMENT AFTER REPORTING THIS INCIDENT. SHE ALSO FILED AN INCIDENT REPORT WITH THE HOSPITAL.

  Patient problems: Abrasion

  MAUDE report 15362713 ↗