Events

Alerte De Sécurité sur Product Name: LYRA II AGLUTINATION REACTION READER - Log: 80004040165 - Model: 854002 - Affected batches / series: 407; 422; 423; 424; 434; 451; 453; 454; 461; 462; 465; 468; 471; LY0H000201; LY0H000203; LY0K000303; LY0K000305; LY0K000306; LY1B000401; LY1B000402; LY1B000403; LY1B000409; LY2C003904; LY2C004004; LY3F007301; LY3F007302; LY3F007303; LY3F007304; LY3F007308; LY3I007507; LYB000407; LYB000410 (SEE SCHEDULE OF DISTRIBUTION IN ANNEX)

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 DIAMED LATINO AMÉRICA S.A..

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
    1643
  • Date
    2015-07-27
  • 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
    Immediate Protective Action - Customer Guidelines: • Use only an empty microplate for balancing purposes. For example: when only one microplate is read; • Check the color of the results presented by the Maestro software during validation; • Do not validate results if well images appear in black and white.
  • Cause
    It has been shown that in exceptional circumstances, the lyra ii agglutination reaction reader software (ms registry 80004040165) may incorrectly attribute the result of a microplate previously read to the microplate being processed. when this occurs, incorrect results are displayed in black and white instead of colored. according to a company risk assessment, "the likelihood of reporting an erroneous outcome is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously. to date, no incident with patient has been reported.".
  • Action
    Company is informing its customers about the problem so that they take the appropriate preventive measures until a definitive solution is released through a new software version. It is reported that "the probability of reporting an erroneous result is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously." To date, no incident with patient has been reported. "; Action: Update, correction or supplementation of the instructions for use Code: AC 2015/02 SEE ATTACHMENTS: (i). Important Notice of Field (AC) - AC Number: 2015/02; (ii) .CORRECTIVE ACTION NOTIFICATION ACKNOWLEDGMENT (AC 2015/02)

Device

Product Name: LYRA II AGLUTINATION REACTION READER - Log: 80004040165 - Model: 854002 - Affected ...

Manufacturer

DIAMED LATINO AMÉRICA S.A.