Events

Safety Alert for Myoglobin Assay in Liquid Cardiac Control Level 1, 2 and 3

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Randox Laboratories.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-02-24
  • Event Date Posted
    2017-02-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170224.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: randox laboratories myoglobin assay in liquid cardiac control level 1, 2 and 3 medical device manufacturer, randox laboratories, has issued a field safety notice (fsn) concerning its myoglobin assay in liquid cardiac control level 1, 2 and 3. details catalogue numbers and lot numbers as below:- catalogue numbers: 1) cq5051; 2) cq5052; 3) cq5053 lot numbers: 1) 3909ck, 3910ck, 3913ck; 2) 3911ck, 3990ck, 3991ck, 3992ck; 3) 3912ck the manufacturer 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 instruction for use (ifu) has not been confirmed. customers using methods other than the randox immunoturbidimetric method should review their running internal quality control (iqc) mean for a shift in trend which may indicate a review of the control range is required. according to the manufacturer, 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. the manufacturer advises customers to remove the ifu from all unused stock and replace with the lot specific document. review results generated with the affected lots in line with the clinical profile of the patient and discuss the contents of the fsn with their medical director. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 february 2017.

Device

Myoglobin Assay in Liquid Cardiac Control Level 1, 2 and 3
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Randox Laboratories Myoglobin Assay
  • Manufacturer
    Randox Laboratories

Manufacturer

Randox Laboratories