Class II — Potential Health Hazard

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

HemosIL LMW Heparin Controls Recalled by Instrumentation Laboratory Due to Multiple complaints indicating lower than expected quality control...

Date: February 3, 2025
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

HemosIL LMW Heparin Controls; Part Number: 0020300200;

Quantity: 41,824 units

Why Was This Recalled?

Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

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