Events

Recall of Device Recall ETIABAUK PLUS

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
    57937
  • Event Risk Class
    Class 2
  • Event Number
    Z-1744-2011
  • Event Initiated Date
    2010-08-19
  • Event Date Posted
    2011-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97783
  • 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
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Reason
    Through internal testing, diasorin has become aware that the kit lots identified (eti-ab-auk plus kits, catalog number p001931, lot numbers 0650270a and/or 0650270a/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. internal testing has confirmed that when defined assay validation criteria pass, analytical performance is co.
  • Action
    The firm, DiaSorin, sent a "Customer Notification Letter" dated 19 August, 2010 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to destroy all remaining inventory and complete and return the receipt of notification and destruction of product form, found in the bottom portion of the letter, via fax to: (651) 351-5669, ATTN: TECHNICAL SERVICES or mail to: ATTN: TECHNICAL SERVICES, 1951 Northwestern Ave., Stillwater, Minnesota 55082-0285. If you have any questions or concerns, please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.

Device

Device Recall ETIABAUK PLUS
  • Model / Serial
    lot numbers 0650270A and 0650270A/1.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: AL, AR, CA, CT, DE, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK OR, PA, TX, VT, VA, WA,and WI; and country of: SOUTH KOREA.
  • Product Description
    ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 || In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
  • 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