ACL ELITE PRO-Analyzer: HemosIL Liquid Anti-Xa test definition removed
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL ELITE/Elite Pro analyzers used in clinical hemostasis laboratories. No illnesses or injuries have been reported.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The specific safety concern is not detailed in the source documentation, making the hazard theoretical rather than confirmed. Removal of a test definition from a clinical device warrants precautionary action but without documented harm meets the criteria for Moderate severity.
Plain-English summary
Instrumentation Laboratory is removing the test definition for HemosIL Liquid Anti-Xa (Part Numbers 0020302600 and 0020302601) from ACL ELITE and ACL ELITE PRO analyzers. These instruments are designed for clinical use in hemostasis laboratories, specifically for coagulation and fibrinolysis testing.
The affected analyzers are distributed worldwide, including 129 units in the United States and 2,686 units internationally. Distribution countries include Canada, European nations, Asia-Pacific countries, Africa, and other regions.
This is a Class II recall. No illnesses or injuries related to this issue have been reported. Instrumentation Laboratory is removing this test capability to address an identified concern with the test definition. Clinical laboratories using these analyzers should follow guidance from Instrumentation Laboratory regarding this removal.
The recalled product
- Product
- ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
- Manufacturer
- Instrumentation Laboratory
- Hazard
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)
- UDI: 08426950451570 Serial Number 23015246 and Prior
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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