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.
What this means for you
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
- test-removal
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.
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