Events

Recall of Pacific Hemostasis ThromboplastinDS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Fisher Diagnostics, A Company of Fisher Scientific LLC.

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
    57107
  • Event Risk Class
    Class 2
  • Event Number
    Z-1519-2011
  • Event Initiated Date
    2010-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95403
  • 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
    Test, time, prothrombin - Product Code GJS
  • Reason
    An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.
  • Action
    The firm, ThermoFisher Scientific, sent two "Urgent Medical Device Removal" letters one via Federal Express on October 20, 2010 and certified mail for domestic customers on October 21, 2010. The letters described the product, problem and action to be taken by the customers. The customers were instructed to indicate the quantities of all affected product currently in stock at their facility; complete and return the attached Response Form/table to Fisher Diagnostics via fax to (540) 869-8129 or by mail to the attention of Technical Support; dispose of any remaining inventory of the affected lot numbers; provide a copy of this letter to their customers, and file this letter for future reference. If you have any questions regarding this notification, please contact our Technical Support staff at 800-528-0494, Option 2, or email techsupport.diagnostics.mtn@themofisher.com.

Device

Pacific Hemostasis ThromboplastinDS
  • Model / Serial
    V40526, exp 4/2013 V40826, exp 4/2013
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: Alaska, Florida, Kentucky, Ohio, New Jersey, New York, and Texas; and countries including: Argentina, Dubai, Italy, Mexico, Philippines, Romania, and Turkey.
  • Product Description
    Pacific Hemostasis ¿ Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** || Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays.
  • Manufacturer
    Fisher Diagnostics, A Company of Fisher Scientific LLC

Manufacturer

Fisher Diagnostics, A Company of Fisher Scientific LLC
  • Manufacturer Address
    Fisher Diagnostics, A Company of Fisher Scientific LLC, 8365 Valley Pike, Middletown VA 22645-1905
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA