Events

Alerte De Sécurité sur ARCHITECT Lactic Acid

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Abbott Laboratories Limited.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-10-13
  • Date de publication de l'événement
    2016-10-13
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161013a.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: abbott architect lactic acid medical device manufacturer, abbott laboratories limited, has issued a medical device safety alert concerning its architect lactic acid [list number: 9d89-21; lot number (expiration date): 31497un14 (17 oct 2016); 09353un15 (12 feb 2017); 45216un15 (12 may 2017); 14596un15 (30 jul 2017); 37055un15 (12 oct 2017); 14782un16 (21 apr 2018)]. the manufacturer has identified negative interference from the drug n-acetyl cysteine (nac) with the architect lactic acid reagent (ln 9d89-21). according to the manufacturer, the levels of interference observed at nac concentrations of 80 mg/l (0.49 mmol/l) and 800 mg/l (4.9 mmol/l) have been outlined in the field safety notice (fsn). patients undergoing treatment with nac may have falsely depressed lactic acid results. the affected users are advised to take the following actions: review the fsn with their medical director taking the fsn into consideration, they may continue to use architect lactic acid reagent (ln 9d89-21) retain the fsn for their laboratory records 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 13 october 2016.

Device

ARCHITECT Lactic Acid
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott ARCHITECT Lactic Acid
  • Manufacturer
    Abbott Laboratories Limited

Manufacturer

Abbott Laboratories Limited
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH