Events

Safety Alert for Labscreen Multi HLA Class I and III and HNA Technical Name: Labscreen Multi HLA Class I and III and HNA Registration Number ANVISA: 80298490004 Hazard Class: III Affected Model: LSMUTR Affected Series Numbers: Lot: 007 Batch: 0000091458 , 0000099706 and 0000145845

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biometrix Diagnóstica Ltda.; One Lambda, Inc..

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
    2289
  • Date
    2017-05-16
  • 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
    Actions to be taken: User guidance to use the Instructions for Use LABScreen Revision 9 (LMMUTRPI Ver 9), which can be consulted on the One Lambda website, and discontinue the document LABScreen Multi Revision 8 (LMMUTRPI Ver 8). If the product was analyzed using LABScan 3D (Luminex FM3D), reanalyze the results using LABScan 100 (Luminex 100/200) to ensure the accuracy of the results.
  • Reason
    Field action code 2018 triggered under the responsibility of the company biometrix diagnostica ltda. company will update, amend or supplement the instructions for use. the manufacturer has notified the distributor that the instruction for use of the labscreen multi hla class i and ii and hna (lsmutr) product containing divergent required instrument information has been released. the code usage instruction lmmutrpi ver 8, released on 04/20/2016 contained as required instrument the labscan 3d equipment, however the required instrument is the labscan 100. the product works as indicated, this error is for documentation only.
  • Action
    Field Action Code 2018 triggered under the responsibility of the company Biometrix Diagnostica Ltda. Company will update, correct or supplement the instructions for use.

Device

Labscreen Multi HLA Class I and III and HNA Technical Name: Labscreen Multi HLA Class I and III a...

Manufacturer

Biometrix Diagnóstica Ltda.; One Lambda, Inc.
  • Source
    ANVSANVISA