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 Heparin Calibrators Recalled by Instrumentation Laboratory Due to Control indicating lower than expected quality control (QC)...

Date: December 18, 2024
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 Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

Quantity: 10,952 units (5,303 US, 5,649 OUS)

Why Was This Recalled?

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

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