Events

Alerte De Sécurité sur S2 FLUID PACK OMNI S, Registration: 10287410150, Lots: 21450781/21450887/21451391

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 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

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
    1630
  • Date
    2015-07-08
  • 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
    The company informs that when an affected S2 Fluid Pack is inserted into the cobas b 221 instrument, it will display the error message "Transponder error" and the instrument can not start the measurement until the affected S2 Fluid Pack is replaced by a packaging that does not present a defect and may lead to a delay in the measurement of the parameters. If the equipment correctly identifies the package, the measurement will proceed normally as there are no problems with the reagent.
  • Cause
    Roche diagnostics gmbh, the manufacturer of the products involved in this notification, after internal investigations identified a possible increase in the generation of transponder errors specific to s2 fluid pack reagent packs from lots 21450781, 21450887 and 21451391. such an error is detected and generated by equipment as soon as an affected s2 fluid pack is inserted, making it impossible to use it. the company informs that not all packs of fluid pack from these batches have been affected and the only way to identify whether or not the product is affected is by inserting the fluid pack fluid pack into the instrument and checking if an error message is indicated.
  • Action
    The company advises that: i) S2 Fluid Pack packages should be replaced if "Transponder error" is indicated. The affected Fluid Pack packaging must be disposed of locally. ii) In case the customer finds the message "Transponder error", we request that you contact our service center CEAC - 08007720295 for treatment of the occurrence.

Device

S2 FLUID PACK OMNI S, Registration: 10287410150, Lots: 21450781/21450887/21451391

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH