Events

Recall of ETIMP IgM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diasorin 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
    30930
  • Event Risk Class
    Class 3
  • Event Number
    Z-0633-05
  • Event Initiated Date
    2004-10-20
  • Event Date Posted
    2005-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36840
  • 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
    N-Acetylprocainamide Control Materials - Product Code LAZ
  • Reason
    2 lots of eti-mp igm assay kits showed a decline in optical density (od) reading of the positive control and calibrators, p10 and p50. the decline in od of the positive control and calibrators (p10 & p50) would cause the assay validation criteria to fail.
  • Action
    Customers were sent notification letters. Recommended to detroy the remaining kits and requested a form be returned which indicates the number of kits destroyed so they can arrange replacement.

Device

ETIMP IgM
  • Model / Serial
    lot # E052660D, E052790D
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    MA, OH & IL
  • Product Description
    ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. manufactured for DiaSorin Inc., 1950 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    USFDA