Home / Recalls / Horiba Instruments, Inc dba Horiba Medical / Z-2286-2018

Z-2286-2018 Class II Terminated

Recalled by Horiba Instruments, Inc dba Horiba Medical — Irvine, CA

Recall Details

Product Type
Devices
Report Date
July 4, 2018
Initiation Date
April 26, 2018
Termination Date
September 26, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
686 devices (233 devices US, 453 devices OUS)

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.

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.

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.

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

Other recalls by Horiba Instruments, Inc dba Horiba Medical

  • Z-0493-2018 Class II — 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA (November 21, 2017)
  • Z-0494-2018 Class II — 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA (November 21, 2017)
  • Z-0902-2015 Class II — ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and (November 13, 2014)
  • Z-2692-2014 Class II — ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENT (August 11, 2014)
  • Z-1173-2014 Class II — Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A So (February 14, 2014)
  • Z-1146-2014 Class II — ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PE (January 20, 2014)
  • Z-0924-2014 Class III — ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (December 18, 2013)
  • Z-0904-2014 Class II — ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use (November 21, 2013)
  • Z-2280-2013 Class III — ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential r (September 6, 2013)
  • Z-1141-2013 Class II — HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE11 (March 20, 2013)