Events

Recall of Device Recall MESOMARK

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

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
    56427
  • Event Risk Class
    Class 3
  • Event Number
    Z-1606-2011
  • Event Initiated Date
    2010-07-29
  • Event Date Posted
    2011-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93728
  • 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
    Cancer monitoring test system, soluble mesothelinrelated peptides, epithelioid/biphasic mesothelioma - Product Code OAW
  • Reason
    Presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.
  • Action
    Notification dated 7/7/10 was sent to the customer via e-mail and FedEx Priority Overnight. FUJIREBIO Diagnostics, Inc. sent an URGENT PRODUCT CORRECTION NOTIIFICATION letter dated July 7, 2010, to all affected customers via e-mail and FedEx Priority Overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue using MESOMARK kit. Lot 57K04510 and discard any remaining inventory. Complete and return the attached Confirmation of Receipt form upon receipt of this notification, no later than July 30, 2010. Notify your ordering physician or health care provider as appropriate. For questions regarding this recall call 877-861-7246 or 610-240-3800.

Device

Device Recall MESOMARK
  • Model / Serial
    Lot: 57K04510, Item # 801-905, Expiration Date: December 14, 2010 and Lot: 57K04409, Item# 801-905, Expiration Date: June 15, 2010
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    HDE
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including UT
  • Product Description
    MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. || MESOMARK is an enzyme linked immunosorbent assay (ELISA) for the quantitative measurement of Soluble mesothelin Related Peptides (SMRP) in human serum. Measurement of SMRP may aid in the monitoring of patients diagnosed with epithelioid or biphasic mesothelioma. MESOMARK values must be interpreted in conjunction with all other available clinical and laboratory data.
  • Manufacturer
    Fujirebio Diagnostics, Inc.

Manufacturer

Fujirebio Diagnostics, Inc.
  • Manufacturer Address
    Fujirebio Diagnostics, Inc., 201 Great Valley Pkwy, Malvern PA 19355-1308
  • Manufacturer Parent Company (2017)
    Miraca Holdings, Inc.
  • Source
    USFDA