Events

Recall of Device Recall BD Unopette System Tests (Erythrocyte Fragility Test Kit).

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

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
    35864
  • Event Risk Class
    Class 2
  • Event Number
    Z-1446-06
  • Event Initiated Date
    2005-06-01
  • Event Date Posted
    2006-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47058
  • 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
    Erythrocyte Fragility Test Kit - Product Code GKE
  • Reason
    Formulation problems-lower ph of the solutions may increase red blood cell hemolysis.
  • Action
    Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005

Device

Device Recall BD Unopette System Tests (Erythrocyte Fragility Test Kit).
  • Model / Serial
    Catalog #365830 -- Lot numbers: 5014328 -- exp. June 2006; 5159075 -- exp. July 2006.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    World wide-USA, Canada, Europe, Asia Pacific.
  • Product Description
    BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA