Events

Safety Alert for 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)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by DIAMED LATINO AMÉRICA S.A..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1643
  • Date
    2015-07-27
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.