Events

Recall of VIDAS Total Prostate Specific Antigen

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

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
    68749
  • Event Risk Class
    Class 2
  • Event Number
    Z-2152-2014
  • Event Initiated Date
    2013-10-14
  • Event Date Posted
    2014-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128597
  • 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
    in vitro diagnostic PSA - Product Code MTF
  • Reason
    Product is not approved or authorized for distribution in the us.
  • Action
    A letter was issued on October 14, 2013 to consignees requesting the consignee to check their stock and destroy all kits of the VIDAS TPSA ref. 30428. The letter also requested that the consignee notify their accounts of the recall. An acknowledgment form was also included with the letter which is to be returned to BioMerieux.

Device

VIDAS Total Prostate Specific Antigen
  • Model / Serial
    Lot 1001904130
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    FL, LA, MI, MS, NV, OH, OK, TN, TX
  • Product Description
    VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
  • Manufacturer
    BioMerieux SA

Manufacturer

BioMerieux SA
  • Manufacturer Address
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA