Events

Recall of Device Recall Rubella IgG ELISA Kit

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
    54124
  • Event Risk Class
    Class 3
  • Event Number
    Z-0922-2010
  • Event Initiated Date
    2009-12-16
  • Event Date Posted
    2010-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87540
  • 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 immunoabsorbent assay, rubella - Product Code LFX
  • Reason
    Diasorin rubella igg kits of lot 123127a were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. the risk is the possibility of delayed patient test results.
  • Action
    Consignees were sent a DiaSorin Customer Notification letter dated December 16, 2009. The Letter was addressed to Customer. The letter described the product and the problem and indicated a replacement product will be provided. Requested consignees to complete the acknowledgement receipt form. For questions or concerns please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.

Device

Device Recall Rubella IgG ELISA Kit
  • Model / Serial
    Lot 123127A
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US distribution: CA, CT, MA, MD, IL, OR
  • Product Description
    DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.
  • 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