Class II — Potential Health Hazard

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

AM1015 Randox Ammonia (NH3) Recalled by RANDOX LABORATORIES, LTD. Due to Randox Ammonia reagents are being recalled from the...

Date: July 30, 2020
Company: RANDOX LABORATORIES, LTD.
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 RANDOX LABORATORIES, LTD. directly.

Affected Products

AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Quantity: 143 kits in total

Why Was This Recalled?

Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.

Where Was This Sold?

This product was distributed to 3 states: UT, VA, WV

Affected (3 states)Not affected

About RANDOX LABORATORIES, LTD.

RANDOX LABORATORIES, LTD. has 7 total recalls tracked by RecallDetector.

Related Recalls

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