Home / Recalls / Horiba Instruments, Inc dba Horiba Medical / Z-1173-2014

Z-1173-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 19, 2014
Initiation Date
February 14, 2014
Termination Date
August 22, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15

Product Description

Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.

Reason for Recall

HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.

Distribution Pattern

USA Nationwide Distribution

Code Information

Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A

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-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)