Class II — Potential Health Hazard

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

TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for Recalled by Haemonetics Corporation Due to Research Use Only (RUO) parameters were included in...

Date: June 20, 2013
Company: Haemonetics Corporation
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 Haemonetics Corporation directly.

Affected Products

TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

Quantity: 1590 devices

Why Was This Recalled?

Research Use Only (RUO) parameters were included in TEG 5000 User Manual.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Haemonetics Corporation

Haemonetics Corporation has 31 total recalls tracked by RecallDetector.

Related Recalls

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