Horiba Instruments Inc: Medical Device Recall in 2016 - (Recall #: Z-0738-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 11, 2016

Date Posted: February 10, 2016

Recall Number: Z-0738-2016

Event ID: 73033

Reason for Recall:

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.

Status: Terminated

Product Quantity: 216

Code Information:

All Lots

Distribution Pattern:

U.S. distribution to the following; CA, NY, AL, OK, MN, MS, MD, TX, KY, WV, MT, IL, FL, VA, WA, MI, KS, NE, PA, OH, ID, OR, AR, AZ, NM, NC, SC, GA, TN No foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated