Home / Recalls / Horiba Instruments Inc / Z-1553-2016

Z-1553-2016 Class II Terminated

Recalled by Horiba Instruments Inc — Irvine, CA

Recall Details

Product Type
Devices
Report Date
May 4, 2016
Initiation Date
February 19, 2016
Termination Date
August 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
201

Product Description

ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.

Reason for Recall

Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.

Distribution Pattern

USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.

Code Information

All lot/serial #s

Other recalls by Horiba Instruments Inc

  • Z-1554-2016 Class II — Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete (February 19, 2016)
  • Z-0741-2016 Class II — ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitati (January 11, 2016)
  • Z-0740-2016 Class II — ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitati (January 11, 2016)
  • Z-0739-2016 Class II — ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the qu (January 11, 2016)
  • Z-0742-2016 Class II — ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for t (January 11, 2016)
  • Z-0743-2016 Class II — ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the (January 11, 2016)
  • Z-0738-2016 Class II — The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for (January 11, 2016)
  • Z-0856-2015 Class II — Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower P (November 19, 2014)