Class II — Potential Health Hazard

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

The ABX PENTRA Cholesterol CP ref. A11A01634 is an in Recalled by Horiba Instruments Inc Due to N-Acetylcysteine (NAC) present in the blood of patients...

Date: January 11, 2016
Company: Horiba Instruments Inc
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 Horiba Instruments Inc directly.

Affected Products

The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.

Quantity: 216

Why Was This Recalled?

N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with the reagents using the Trinder reaction method.

Where Was This Sold?

This product was distributed to 29 states: AL, AZ, AR, CA, FL, GA, ID, IL, KS, KY, MD, MI, MN, MS, MT, NE, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV

Affected (29 states)Not affected

About Horiba Instruments Inc

Horiba Instruments Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

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