Events

Recall of Randox Myoglobin Assay

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Randox Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00340-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00340-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Randox has confirmed a change in recovery with regards to myoglobin in the lots of the liquid cardiac control listed above for the randox immunoturbidimetric method. internal testing of the affected lots has shown an increased rate of degradation for myoglobin only. new targets and control ranges have therefore been assigned for the randox immunoturbidimetric method. recovery of myoglobin for other methods quoted in the ifu has not been confirmed. customers using methods other than the randox immunoturbidimetric method should review their running iqc mean for a shift in trend which may indicate a review of the control range is required.Iqc that is reported as out of range could lead to a delay in reporting myoglobin results. since serum myoglobin is not typically used in isolation for diagnosing cardiac injury a delay in reporting these results should not pose a serious risk to health.
  • Action
    Users are notified to remove the existing IFU from all unused stock and replace it with the lot specific document provided with the customer letter. Also, users are advised to discuss the contents of customer letter with their Medical Director and review results generated with the affected batches in line with the clinical profile of the patient.

Device

Randox Myoglobin Assay
  • Model / Serial
    Randox Myoglobin AssayCatalogue Numbers: CQ5051, CQ5052, CQ5053Batch Numbers: 3909CK to 3913CK; 3990CK to 3992CKARTG Number: 208141
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA