The Recall Desk
ModerateFDA (Devices)·Z-0151-2022·Announced 2021-10-27

HemosIL Liquid Anti-Xa Assay On-Board Stability Issue Recall

Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, a coagulation assay measuring heparin activity, due to reduced on-board instrument stability from 7 days to 5 days.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries. The issue involves reduced on-board instrument stability for a laboratory device, representing a device performance change rather than an explicitly identified patient safety hazard. This falls under the category of voluntary precautionary recalls.

Plain-English summary

Instrumentation Laboratory is recalling all currently released and future lots of HemosIL Liquid Anti-Xa, an automated chromogenic assay used to measure unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma. The device runs on IL Coagulation Systems including ACLTOP Family, ACL TOP Family 50 Series, and ACL Elite/Elite Pro analyzers. Approximately 40,224 units have been distributed in the United States and internationally.

The recall addresses a labeling issue regarding on-board instrument stability. The stability period for on-board materials has been reduced from 7 days to 5 days for both current and future lots.

The affected device is used in clinical laboratories and hospitals across the United States and in more than 40 countries worldwide, including Canada, Australia, Austria, Belgium, Brazil, China, France, Germany, Japan, Mexico, and the United Kingdom.

Healthcare facilities that have received this product should review updated stability information and ensure that on-board materials are not used beyond the 5-day stability period. Facilities should contact Instrumentation Laboratory with any questions regarding this recall.

The recalled product

Product
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/E
Manufacturer
Instrumentation Laboratory
Category
Medical Device — Coagulation Analyzer Assay
Hazard
  • stability-issue

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All currently released lots and future lots

Distribution

Distributed nationwide across the United States.

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