Class II — Potential Health Hazard

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

ROTEM ex-tem Canada Part No: 503-05-CA Recalled by Instrumentation Laboratory Co. Due to Prolonged clotting times

Date: July 23, 2019
Company: Instrumentation Laboratory Co.
Status: Terminated
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 Co. directly.

Affected Products

ROTEM ex-tem Canada Part No: 503-05-CA

Quantity: 44 kits

Why Was This Recalled?

Prolonged clotting times

Where Was This Sold?

This product was distributed to 3 states: IL, MI, WI

Affected (3 states)Not affected

About Instrumentation Laboratory Co.

Instrumentation Laboratory Co. has 31 total recalls tracked by RecallDetector.

Related Recalls

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