BEUDAMED
    FDA Recall Terminated

    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).

    Recall: Z-2692-2014 · Initiated August 11, 2014

    Recall

    Recall Number
    Z-2692-2014
    Event Number
    69105
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    FEI Number
    3002698356
    Product Code
    JGJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2014
    Posted
    September 24, 2014
    Terminated
    November 25, 2014
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    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

    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.

    Action

    Horiba sent an Urgent Safety Notice letter dated August 11, 2014 to all customers running the Magnesium RTU assay on the ABX PENTRA 400 Chemistry analyzers that the On-Board Stability has been updated. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. For questions call 888-903-5001, ext 4266.

    Distribution

    US Nationwide Distribution.

    Quantity

    359 units