Events

Recall of Device Recall Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wiener Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79181
  • Event Risk Class
    Class 2
  • Event Number
    Z-0924-2018
  • Event Initiated Date
    2017-11-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161541
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Enzyme linked immunosorbent assay, t. Cruzi - Product Code MIU
  • Reason
    Internal program testing shows that product may not reach the indicated expiration date.
  • Action
    On about November 10, 2017, customers were notified via email of the recall. Instructions include to examine inventory and cease distribution of the device, make arrangements to return affected devices, acknowledge receipt of the recall notification, and notify customers if further distributed.

Device

Device Recall Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0
  • Model / Serial
    Product Code 1293254, Lot Code 1709228140
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : Florida and Washington DC. , and to the countries of : Argentina, Bolivia, Brasil, and Costa Rica.
  • Product Description
    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 || Diagnosis of Chagas disease.
  • Manufacturer
    Wiener Laboratories

Manufacturer

Wiener Laboratories
  • Manufacturer Address
    Wiener Laboratories, Street, Riobamba Argentina
  • Source
    USFDA