Events

Alerte Ou Avis De Sécurité sur Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Eurotrol B.V.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2019-01-30
  • Date de publication de l'événement
    2019-01-30
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/recall-of-certain-batches-of-eurotrol-haemoglobin-controls-due-to-microbial-contamination-mda-2019-005
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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