Events

Recall of BD BBL Staphyloslide Latex Test Kit

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
    35794
  • Event Risk Class
    Class 2
  • Event Number
    Z-1505-06
  • Event Initiated Date
    2006-08-17
  • Event Date Posted
    2006-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48291
  • 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
    Staphyloslide Latex Test Kit - Product Code LHJ
  • Reason
    False negative staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the positive control to react within 20 seconds. the failure is due to reduced reactivity of the latex component.
  • Action
    The recalling firm notified distributors and end users by e-mail, faxed letters, and certified courier on 08/17/06.

Device

BD BBL Staphyloslide Latex Test Kit
  • Model / Serial
    Lot Number / Exp. Date 16629910 April 30, 2007-Cat # 240952 16562410 April 30, 2007-Cat # 240952 16629920 April 30, 2007-Cat # 240953 16562420 April 30, 2007-Cat # 240953
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-product was sold to distributors and end users
  • Product Description
    BD¿ BBL¿ Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.
  • 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