Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2014 - (Recall #: Z-0924-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.

Product Classification:

Class III

Date Initiated: December 18, 2013

Date Posted: February 12, 2014

Recall Number: Z-0924-2014

Event ID: 67133

Reason for Recall:

HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.

Status: Terminated

Product Quantity: 531

Code Information:

Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated