Home / Recalls / Horiba Instruments, Inc dba Horiba Medical / Z-2692-2014

Z-2692-2014 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 1, 2014
Initiation Date
August 11, 2014
Termination Date
November 25, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
359 units

Product Description

ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).

Reason for Recall

Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.

Distribution Pattern

US Nationwide Distribution.

Code Information

All Lots

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-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)