Events

Alerte De Sécurité sur CELL-DYN RUBY Technical Name: HEMATOLOGICAL ANALYZER ANVISA Registration Number: 80146501507 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 70002BG; 70026BG; 70050BG; 70076BG; 70105BG; 70141BG; 70003BG; 70028BG; 70051BG; 70077BG; 70106BG; 70142BG; 70004BG; 70029BG; 70052BG; 70079BG; 70107BG; 70144BG; 70005BG; 70030BG; 70054BG; 70082BG; 70113BG; 70146BG; 70006BG; 70031BG; 70056BG; 70084BG; 70114BG; 70147BG; 70007BG; 70032BG; 70058BG; 70086BG; 70119BG; 70149BG; 70008BG; 70033BG; 70059BG; 70087BG; 70120BG; 70164BG; 70009BG; 70034BG; 70061BG; 70088BG; 70124BG; 70165BG; 70010BG; 70035BG; 70063BG; 70089BG; 70125BG; 70166BG; 70011BG; 70036BG; 70064BG; 70090BG; 70127BG; 70167BG; 70012BG; 70037BG; 70065BG; 70091BG; 70129BG; 70170BG; 70013BG; 70038BG; 70067BG; 70092BG; 70130BG; 70171BG; 70014BG; 70039BG; 70068BG; 70093BG; 70131BG; 70178BG; 70016BG; 70040BG; 70069BG; 70094BG; 70132BG; 70181BG; 70018BG; 70042BG; 70070BG; 70095BG; 70133BG; 70183BG; 70019BG; 70043BG; 70071BG; 70096BG; 70134BG; 70189BG; 70020BG; 70044BG; 70072BG; 70099BG; 70136BG; 70021BG; 70045BG; 70073BG; 70100BG; 70137BG; 70024BG; 70046BG; 70074BG; 70103BG; 70138BG; 70025BG; 70047BG; 70075BG; 70104BG; 70140BG.

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; ABBOTT LABORATORIES.

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
    2213
  • Date
    2017-03-02
  • 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
    1. Your Abbott service team will contact you to replace the PCBA Pump Relay Plate on the impacted equipment (s) at no cost. 2. Make sure you have a back-up device or alternate method to generate hematology results if the equipment becomes inoperative. 3. If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice. 4. Keep this statement in your lab files. #### Update of the field action: UPDATED ON 09/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Abbott hematology has learned that the cell-dyn ruby equipment in its laboratory has a printed circuit board (pcba) assembly that may fail prematurely and result in loss of vacuum / pressure. the pcba pump relay board failure will result in system started messages (sims), including but not limited to the following, and will no longer function: 0840 vacuum accumulator # 1 wet, 1093 mix head failed to complete downward rotation, 1095 mix head not top position, 1096 mix head stuck at top position, 0643 wbc lyse empty * [empty wbc lysis reagent *], 0645 dil / sheath empty *. for messages 0643 and 0645, make sure that the reagent is not empty. if the error message is related to this problem, the machine will stop and you will need to replace the pcba to continue.
  • Action
    Field Action Code FA13FEB2017 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

CELL-DYN RUBY Technical Name: HEMATOLOGICAL ANALYZER ANVISA Registration Number: 80146501507 Haza...

Manufacturer

Abbott Laboratórios do Brasil; ABBOTT LABORATORIES
  • 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