FDA recalls ACL ELITE refurbished analyzer to remove Anti-Xa test
Instrumentation Laboratory recalled ACL ELITE refurbished coagulation analyzers to remove the HemosIL Liquid Anti-Xa test definition.
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: Class II medical device recall involving removal of a critical laboratory test used in anticoagulation therapy monitoring. While no adverse events, illnesses, injuries, or deaths are documented in the source, this qualifies as a risk-of-harm product where the issue with the Anti-Xa test could affect patient safety if left operational. Per the rubric, risk-of-harm products without reported injury are scored as High.
Plain-English summary
Instrumentation Laboratory is recalling ACL ELITE and ACL ELITE Pro refurbished analyzers (Part Number 0000880311R, Serial Number 11121320R and Prior) with UDI 08426950965572. The recall action involves removing the test definition for HemosIL Liquid Anti-Xa (Part Numbers 0020302600 and 0020302601) from these instruments, which are designed for coagulation and fibrinolysis testing in clinical hemostasis laboratories.
The affected analyzers have been distributed worldwide, including throughout the United States, Canada, and over 50 additional countries including the United Kingdom, France, Germany, Japan, Australia, and others.
The recalled product
- Product
- ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
- Manufacturer
- Instrumentation Laboratory
- Hazard
- Affected units
- 1
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: 08426950965572 Serial Number 11121320R 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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