Class II — Potential Health Hazard

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

Sentinel MULTIGENT Ammonia Ultra Reagent Recalled by Sentinel CH SpA Due to Results for ammonia are below the linear range...

Date: September 22, 2015
Company: Sentinel CH SpA
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 Sentinel CH SpA directly.

Affected Products

Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

Quantity: 765 kits

Why Was This Recalled?

Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sentinel CH SpA

Sentinel CH SpA has 7 total recalls tracked by RecallDetector.

Related Recalls

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