Events

Recall of Device Recall Simplastin Excel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Biomerieux, 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
    25587
  • Event Risk Class
    Class 2
  • Event Number
    Z-0629-03
  • Event Initiated Date
    2003-02-04
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26108
  • 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
    Product is being recalled due to vial to vial variability of clotting time results.
  • Action
    Consignees were notified by a Customer Notification letter sent via regular mail on/about February 4, 2003 with response form attached. An additional cover letter was sent to international affiliates/distributors who were responsible for notifying their customers. Consignees were asked to report the amount of product on hand and to destroy the product. On March 18th the firm expanded the recall. Consignees were notified by letter on March 19th , and March 31, 2003 and were advised to stop using the affected lot numbers, destroy the remaining material in inventory and to contact their local bioMerieux Customer Service representative for replacement.

Device

Device Recall Simplastin Excel
  • Model / Serial
    Lot numbers: 161402, 161431, 161432, 161477, 161448, 161479, 161507, 161508, 161550, 161551, 161583, 161585, 161595, 161657, 161658. Expanded 3/19/2003 to include lot #161639, 16160 and 1611711. Final expansion of recall initiated 5/30/2003 to include Product Number 252001 (20ml), lot numbers161403, 161480, 161509, 161510, 161552 161586 and 161596.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide and Brazil, Canada, China, Japan, Korea, Mexico, The Netherlands, Taiwan, Venezuela
  • Product Description
    Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations, bioMerieux, Inc. Durham, NC 27704. The product consists of two vials, a thromboplastin reagent and a diluent ( the vials are mixed together before use).
  • Manufacturer
    Biomerieux, Inc.

Manufacturer

Biomerieux, Inc.
  • Manufacturer Address
    Biomerieux, Inc., 100 Rodolphe Street, Durham NC 27712
  • Source
    USFDA