Horiba Instruments Inc: Medical Device Recall in 2016 - (Recall #: Z-0741-2016)

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:

ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Product Classification:

Class II

Date Initiated: January 11, 2016

Date Posted: February 10, 2016

Recall Number: Z-0741-2016

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