Events

Safety Alert for AUTO D-DIMERO AMAX CRS126-B - Registered in Anvisa under the number 10071770465 - LOTS: T082003 / T084001 / T119006.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medlab Produtos Médico Hospitalares 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
    981
  • Date
    2009-09-17
  • 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
    Observe that the instructions for use of the product indicate that the results should be used with other clinical information and laboratory diagnosis, for the formation of the diagnosis and for the follow-up of the patient. Although it is estimated that the clinical risk is low, it is recommended that the end-user check the calibration curves and make the appropriate determination based on the use of the test and re-test any high sample whose result may be underestimated. Anvisa is following this field action.
  • Reason
    The company reports that after internal investigation, when the calibration curve was generated with the reference batches of the auto d-dimero amax crs126-b product, it was observed that there is a possibility that the two highest points of the curve are not distinguished from one of the and the very high values ​​of dimero d, although they remain high, can be underestimated. a research test showed that in some cases samples greater than 30,000 ng / ml fell within the calibration curve without dilution. there is no indication that this fact could cause an increase in the normal value of d-dimer.
  • Action
    The actions recommended to users of the product are as follows: (1) Immediately stop using the product; (2) Locate the product with the affected batches in your inventory and segregate them. (2) Return them to the dealer for disposal. (3) Forward the Form for Verification and Traceability Response to Medlab Produtos Médico-Hospitalares Ltda. - A / C Luiz Alberto Marin - Phone: (011) 2131-5137 or e-mail luiz.marn@medlabgroup.com.br.

Device

AUTO D-DIMERO AMAX CRS126-B - Registered in Anvisa under the number 10071770465 - LOTS: T082003 /...

Manufacturer

Medlab Produtos Médico Hospitalares Ltda.
  • Source
    ANVSANVISA