Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2018 - (Recall #: Z-2286-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.

Product Classification:

Class II

Date Initiated: April 26, 2018

Date Posted: July 4, 2018

Recall Number: Z-2286-2018

Event ID: 80022

Reason for Recall:

When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.

Status: Terminated

Product Quantity: 686 devices (233 devices US, 453 devices OUS)

Code Information:

All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400

Distribution Pattern:

Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated