Events

Alerte De Sécurité sur Trade name: CELL-DYN Emerald Cleaner / CELL-DYN Emerald Cleaner; ANVISA registration number: 80146501650; lots: 6901 and 6953; quantity of the affected lot: 104 units (distributed as follows: 41 in São Paulo-SP, 12 in Ouro Preto do Oeste-RO, 16 in Rio de Janeiro-RJ, 16 in Duque de Caxias-RJ, 7 in Brasília-DF ; 12 in Rio Branco-AC).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ABBOTT LABORATÓRIOS DO BRASIL LTDA; ABBOTT IRELAND DIAGNOSTICS DIVISION.

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
  • ID de l'événement
    1874
  • Date
    2016-04-11
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Recommendations to Users and Patients: If you HAVE an alternative lot of Emerald Cleaner available in stock (except 6853, 6901 or 6953), immediately discontinue use of impacted Emerald Cleaner lots. 1. Start using the alternative lot of Emerald Cleaner. 2. Perform the Decontamination Procedure in accordance with the CELL-DYN Emerald Operations Manual (9140859 version H), pages 9-16, steps 1 -3. (See Appendix 1.) This will take 15 to 30 minutes. 3. Check QC and follow any additional laboratory procedures. Return the remaining stock of the impacted batches of Emerald Cleaner according to your laboratory procedures. If you have any questions regarding this action, please contact the local Customer Service Center (0800-9099) and mention the number of this field action: FA24MAR2016.
  • Cause
    Abbott identified occurrences where the cell-dyn emerald analyzer generated qc results outside the low range for the rbc and plt parameters. abbott is still investigating the problem, but immediate action is needed. as indicated in the risk assessment, abbot concludes that the frequency of occurrence is 0.61%. the following factors should be considered to estimate the likelihood for irreversible injury caused by a delay in results: some laboratories may have alternative methods to obtain a result in a timely manner. physicians can take patient history and physical examination into account to avoid serious injury in cases where results are delayed.
  • Action
    Action code FA24MAR2016. Preparation of communication of collection of April 8, 2016 for customers who own lots 6901 and 6953 ////// Collection.

Device

Trade name: CELL-DYN Emerald Cleaner / CELL-DYN Emerald Cleaner; ANVISA registration number: 8014...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA; ABBOTT IRELAND DIAGNOSTICS DIVISION
  • 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
    ANVSANVISA