Events

Recall of Device Recall Coagulation Factor VIII Deficient Plasma (OTXW)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dade Behring , 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
    32691
  • Event Risk Class
    Class 3
  • Event Number
    Z-1374-05
  • Event Initiated Date
    2005-07-08
  • Event Date Posted
    2005-08-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40572
  • 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
    Plasma, Coagulation Factor Deficient - Product Code GJT
  • Reason
    Sample may exhibit falsely high results.
  • Action
    On 7/13/05, the recalling firm issued letters to their customers informing them of the problem and the need to discontinue use and to discard any remaining product.

Device

Device Recall Coagulation Factor VIII Deficient Plasma (OTXW)
  • Model / Serial
    Lot numbers 503845A, 503846A, and 503847D
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities and laboratories in AR, AZ, CA, FL, GA, ID, IL, IN, KS, KY, MA, MD, NC, ND, NV, NY, OH, OK, PA, TX, VA, WA, WI, and WV. The products were also shipped to Germany, Belgium, Switzerland, Sweden, Netherlands, Russia, Spain, France, Italy, Portugal, Australia, Chile, China, Saudi Arabi, Taiwan, and Uraguay.
  • Product Description
    Coagulation Factor VIII Deficient Plasma (OTXW). Factor Deficiency Test
  • Manufacturer
    Dade Behring , Inc.

Manufacturer

Dade Behring , Inc.
  • Manufacturer Address
    Dade Behring , Inc., 500 GBC Dr., Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Source
    USFDA