Events

Recall of Device Recall Shigella Antiserum Poly Group B

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

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
    46323
  • Event Risk Class
    Class 2
  • Event Number
    Z-1528-2008
  • Event Initiated Date
    2007-11-30
  • Event Date Posted
    2008-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68191
  • 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
    Antisera, shigella - Product Code GNB
  • Reason
    In vitro diagnostic test reagent for identification of shigella bacteria in patient samples may cause false negative results.
  • Action
    The recalling firm notified distributors by faxed letter flagged as "Urgent Product Recall" and e-mail on 11/30/07. Distributors were instructed to cease distribution and discard identified product and return a list of end user consignees for direct notification by Becton Dickinson. End users were notified by letter flagged as an "Urgent Product Recall" on 11/30/06 through 12/06/07. Customers were instructed to discontinue and discard affected product for replacement. The notification included a reply form that BD requested users to fax back with the quantity of replacement vials needed.

Device

Device Recall Shigella Antiserum Poly Group B
  • Model / Serial
    Lot 6009070 Exp November 03, 2011
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL vials and labeled in part ***Lee Laboratories, Inc Grayson, Georgia 30017*** || Used for the identification of Shigella species by the slide agglutination test
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA