Heparin Activity Assay Labeling Correction: Reduced On-Board Stability
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa kits due to a labeling correction. The on-board stability window has been reduced from 7 to 5 days.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 with no reported illnesses, injuries, or hospitalizations. The issue is a labeling and stability documentation correction—a reduced shelf-life window from 7 to 5 days—which qualifies as a minor labeling correction with no reported harm.
Plain-English summary
Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa, an automated chromogenic assay used to measure heparin activity in blood samples on IL Coagulation Systems analyzers (ACL TOP Family, ACL TOP Family 50 Series, and ACL Elite/Elite Pro/8/9/10000).
The FDA has classified this recall as Class II due to a labeling correction affecting all currently released lots and all future lots. The on-board instrument stability of the product has been reduced from 7 days to 5 days, and this change is reflected in updated labeling.
Approximately 64,114 units have been distributed nationwide in the United States and internationally across multiple countries including Canada, France, Germany, Japan, South Korea, and others.
Healthcare providers and laboratories using this product should observe the revised 5-day on-board stability window and not use reagents beyond that timeframe. Contact Instrumentation Laboratory for additional information regarding this labeling correction.
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, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL…
- Manufacturer
- Instrumentation Laboratory
- Affected units
- 64,114
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.
Part of a larger recall action
This product is one of 3 recalled by Instrumentation Laboratory under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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