Class II — Potential Health Hazard

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

The product is used for the evaluation of the intrinsic coagulation pathway Recalled by Instrumentation Laboratory Due to Potential for microbial contamination.

Date: December 11, 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

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Quantity: 7,720 units

Why Was This Recalled?

Potential for microbial contamination.

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