Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2013 - (Recall #: Z-0645-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

Product Classification:

Class II

Date Initiated: September 20, 2012

Date Posted: January 16, 2013

Recall Number: Z-0645-2013

Event ID: 63829

Reason for Recall:

Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software

Status: Terminated

Product Quantity: 10 units

Code Information:

Lot/Serial# PML0937

Distribution Pattern:

Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.

Voluntary or Mandated:

Voluntary: Firm initiated