Events

Safety Alert Or Field Safety Notices for Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Eurotrol B.V.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2019-01-30
  • Event Date Posted
    2019-01-30
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/recall-of-certain-batches-of-eurotrol-haemoglobin-controls-due-to-microbial-contamination-mda-2019-005
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    The manufacturer has informed the MHRA that due to microbial contamination of quality controls, users may get readings below the values assigned to the product.There is a risk of 2 possible situations occurring:a functional haemoglobin analyser wrongly failing its quality control (QC) test, resulting in a delay in results as the analyser cannot be used on patient samples
    a faulty haemoglobin analyser is wrongfully passed during its quality control (QC) test, possibly leading to an incorrect treatment.The Eurotrol haemoglobin controls are intended for professional use in the verification of the precision and accuracy of haemoglobin analysers. The purpose of these quality controls is to check calibration and other performance related characteristics.The manufacturer has taken the action to remove the products from the market and provide alternative batches to prevent interrupted use of the products.
  • Reason
    Manufactured by eurotrol b.V – may give readings below the values assigned to the product, leading to incorrect measurement results.
  • Action
    Identify affected lots, which are listed in the manufacturer’s Field Safety Notice (FSN) Ensure all relevant members of staff receive the manufacturer’s FSN and that they understand the problem and actions to be taken. Complete and return the acknowledgement form in the FSN. Follow the manufacturer’s actions listed in the FSN until advised otherwise by the manufacturer. Report adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.

Device

Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/20...

Manufacturer

Eurotrol B.V