Events

Safety Alert for IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATORIOS DO BRASIL LTDA.

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
    757
  • Date
    2003-11-25
  • 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
    Recommendations: 1 - Identify if the product IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710 is in use or in stock. 2 - Discontinue use of the IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry no. 10055310710. Store this material in your laboratory for later return to Abbott Laboratories - Diagnostics Division. 3 - Fill in the Response Protocol and send to fax 0xx11 - 5536 7181, for the subsequent return of the product. The company will collect the material and provide a refund. If you have any further questions or concerns, please contact the Customer Service Center at 0800 119099, or contact your local representative.
  • Reason
    The product imx tacrolimus ii calibrators no. 3c10-01, lot no. 94164m100 may present instability of the calibrators during the calibration of the imx tacrolimus reagents test, generating the following messages on the imx instrument: code 157: check 1 out of range, code 159: check 3 out of range and code 161: check 5 out of range.
  • Action
    The Abbott Laboratories-Diagnostics Division has reviewed the available data and concludes that: The use of the IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Batch No. 94164M100 may generate an increase in calibration error codes when using a few batches of the reagent IMX TACROLIMUS II Reagents (list no. 3C10-20). Results of patients who were refueled with the valid calibration curve and test control values ​​within the expected range were not affected and are considered valid. The Abbott Laboratories-Division Diagnostics is conducting research to determine the cause of this instability.

Device

IMX TACROLIMUS II CALIBRATORS no. 3C10-01, Lot no. 94164M100, Anvisa Registry nº 10055310710

Manufacturer

ABBOTT LABORATORIOS DO BRASIL LTDA
  • Source
    ANVSANVISA