Events

Recall of Device Recall GEM Check Coag Whole Blood Controls

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Technidyne Corporation.

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
    56169
  • Event Risk Class
    Class 2
  • Event Number
    Z-2107-2010
  • Event Initiated Date
    2010-07-08
  • Event Date Posted
    2010-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92829
  • 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
    Coagulation Control Plasma - Product Code GGN
  • Reason
    Certain lots of gem check coag whole blood controls contain an error in the package insert where the incorrect acceptable performance ranges were published.
  • Action
    Urgent: Medical Device Correction Notices, dated July 1, 2010, were sent by Federal Express on July 8, 2010 to all first consignee end users. The letters identified the affected product and asked customers to review and follow all instructions as outlined in the ITC in the communication. The info should be shared with laboratory staff and the notification should be retained as part of the laboratory Quality System documentation. The enclosed response form should be completed and returned to ITC within 5 days.

Device

Device Recall GEM Check Coag Whole Blood Controls
  • Model / Serial
    Part Number 06260061600; Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
  • Product Description
    GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: || IVD. 15/pk. 06260061600. || Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. || Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
  • Manufacturer
    International Technidyne Corporation

Manufacturer

International Technidyne Corporation
  • Manufacturer Address
    International Technidyne Corporation, 20 Corporate Pl S, Piscataway NJ 08854-6144
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA