Events

Recall of SPOTTEST LACTOPHENOL COTTON BLUE STAIN

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
    54068
  • Event Risk Class
    Class 3
  • Event Number
    Z-0978-2010
  • Event Date Posted
    2010-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87349
  • 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
    Discs, strips and reagents, microorganism differentiation - Product Code JTO
  • Reason
    An in-vitro diagnostic reagent used by clinical laboratories was mislabeled.
  • Action
    An "URGENT PRODUCT RECALL" notice dated September 2009 was issued via UPS letter to customers. The notification letter described the product, problem and the action to be taken by customer. The recalling firm notified distributors and end users to discontinue use of the identified product and discard for replacement. The customers were requested to return an enclosed response form. The customers were requested to provide, within one week, an excel file or a list with name, address and phone number of end-users who were shipped the product from their distribution branches so that the BD may inform them of the issue. For further assistance regarding product replacement contact our Customer Service Department at 1-800-675-0908. For all other inquiries call our Technical Services Department at 1-800-638-8663.

Device

SPOTTEST LACTOPHENOL COTTON BLUE STAIN
  • Model / Serial
    Lot 9111351, exp 01/31/2012
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Puerto Rico, Korea, and Singapore.
  • Product Description
    BBL(tm) Lactophenol Cotton Blue Stain Droppers, Catalog number 261188, shelf package of 50 droppers, incorrectly labeled in part ***Methylene Blue Loeffler***Becton Dickinson and Company***Packaged in Mexico*** || Lactophenol cotton blue is a blue stain used for direct examination of clinical specimens for fungal elements.
  • 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