ACL TOP 970 CL 00000280097Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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 16, 2026.

Recalls naming this device

1. Jul 13, 2023Open, 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, 2022Open, 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 ↗