Class II — Potential Health Hazard

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

Eon 100 system included the following product reference numbers and Recalled by ELITech Clinical Systems SAS Due to ELITech clinical Systems reagents based on Trinder reaction...

Date: September 22, 2015
Company: ELITech Clinical Systems SAS
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 ELITech Clinical Systems SAS directly.

Affected Products

Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL)

Quantity: 1389 systems

Why Was This Recalled?

ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ELITech Clinical Systems SAS

ELITech Clinical Systems SAS has 6 total recalls tracked by RecallDetector.

Related Recalls

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