Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ACL ELITE PRO-Analyzer designed specifically for clinical use in the Recalled by Instrumentation Laboratory Due to Removes the test definition for HemosIL Liquid Anti-Xa...

Date: February 3, 2023
Company: Instrumentation Laboratory
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Instrumentation Laboratory directly.

Affected Products

ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

Quantity: 129 units US; 2686 units OUS

Why Was This Recalled?

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Instrumentation Laboratory

Instrumentation Laboratory has 38 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report