ACL Elite Analyzer HemosIL Liquid Anti-Xa test definition removal
Instrumentation Laboratory is removing the HemosIL Liquid Anti-Xa test definition from ACL Elite/Elite Pro Analyzers. This affects 358 units in the US and 558 units internationally.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall, which indicates potential for medically reversible adverse health consequences. No illnesses or injuries have been reported. The removal of a specific test definition from medical analyzers used in clinical hemostasis testing represents a risk-of-harm situation where injury has not yet been reported.
Plain-English summary
Instrumentation Laboratory is recalling ACL Elite and Elite Pro Analyzer instruments to remove the HemosIL Liquid Anti-Xa test definition (part numbers 0020302600 and 0020302601) from the analyzer software.
The recall affects 358 units distributed in the United States and 558 units distributed internationally across countries including Canada, Australia, China, India, Japan, Germany, the United Kingdom, and many others. These instruments are used in hemostasis laboratories for coagulation and fibrinolysis testing.
The recalled analyzers are ACL ELITE model with part number 0000880311. The recall includes instruments with serial numbers 23012282 and prior.
The recalled product
- Product
- ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
- 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: 08426950453017 Serial Numbers 23012282 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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