Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2014 - (Recall #: Z-0904-2014)

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 N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.

Product Classification:

Class II

Date Initiated: November 21, 2013

Date Posted: February 12, 2014

Recall Number: Z-0904-2014

Event ID: 66912

Reason for Recall:

Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.

Status: Terminated

Product Quantity: 698 units total (80 units in US)

Code Information:

Lot No. 1300801

Distribution Pattern:

Worldwide Distribution - USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated