BEUDAMED
    FDA Recall Open, Classified

    Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074

    Recall: Z-2446-2023 · Initiated June 21, 2023

    Recall

    Recall Number
    Z-2446-2023
    Event Number
    92710
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JJY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 21, 2023
    Posted
    August 23, 2023

    Description

    Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074

    Reason

    (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. (3) There has been a transcription error for Creatinine in the Instructions For Use (IFU). The target and ranges for Creatinine for the Roche Creatinine Plus method have been listed incorrectly. These failures cause a delay in patient results for the above mentioned analytes.

    Action

    Randox Laboratories issued Medical Device Removal letter to the distribution center within the USA and P. Rico dated June 28, 2023. The distributor will then contact the customer directly via email. Letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any of the above immediately. Provide Randox with photographic evidence of the destruction of the kits. " Review your inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review previous results for this controls and ensure patient results were not reported if control results were not within range. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AR, FL, GA, OH, VA including PR and WW distribution.

    Quantity

    39 units