Home / Recalls / Horiba Instruments, Inc dba Horiba Medical / Z-1050-2013

Z-1050-2013 Class III Terminated

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

FDA device recall Z-1050-2013 was initiated by Horiba Instruments, Inc dba Horiba Medical on February 15, 2013 and is designated Class III. Reason for recall: Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions. The recall status is terminated (terminated August 11, 2014). Affected quantity: 180 units.

Recall Details

Product Type
Devices
Report Date
April 10, 2013
Initiation Date
February 15, 2013
Termination Date
August 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 units

Product Description

ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.

Reason for Recall

Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

Distribution Pattern

Nationwide Distribution

Code Information

All serial numbers

Other recalls by Horiba Instruments, Inc dba Horiba Medical

  • Z-2286-2018 Class II — ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is i (April 26, 2018)
  • 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)

FDA data resources