BEUDAMED
    FDA Recall Terminated

    Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

    Recall: Z-1057-2019 · Initiated February 13, 2019

    Recall

    Recall Number
    Z-1057-2019
    Event Number
    82195
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 13, 2019
    Terminated
    April 14, 2020

    Description

    Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

    Reason

    An error in the assignment of the control range pH in Blood Gas Control

    Action

    The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction " letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following: " Please replace the amended value sheet within the kit of any remaining stock. " Discuss the contents of this notice with your Medical Director. " Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form 12187-QA to [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services by email at [email protected], or telephone +44 (0)28 9442 2413 or Email: [email protected].

    Distribution

    US Distribution to state of: WV

    Quantity

    1 kit