ACL ELITE PRO analyzer test definition removal for Anti-Xa reagent
Instrumentation Laboratory is removing test definitions for HemosIL Liquid Anti-Xa reagent from ACL Elite and Elite Pro analyzers with Serial Number 16053360R and prior. The recall affects 33 units distributed worldwide.
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 corrective action taken via test definition removal. The source text does not report illnesses, injuries, or clinical incidents. The action is corrective rather than responsive to documented patient harm.
Plain-English summary
Instrumentation Laboratory is removing the test definition for HemosIL Liquid Anti-Xa reagents (Part Numbers 0020302600 and 0020302601) from ACL Elite and ACL Elite Pro analyzers. The removal applies to refurbished analyzer units with Serial Number 16053360R and prior.
This recall affects 33 refurbished ACL ELITE PRO analyzer units with UDI 08426950453482 that have been distributed worldwide, including throughout the United States and internationally.
Laboratories using affected analyzers should discontinue use of the HemosIL Liquid Anti-Xa test on the identified units. Contact Instrumentation Laboratory for instructions on updates or corrective actions.
The recalled product
- Product
- ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
- Manufacturer
- Instrumentation Laboratory
- Hazard
- Affected units
- 33
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: 08426950453482 Serial Number 16053360R 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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