Events

Recall of Device Recall Minutex DDimer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tcoag Us, Incorporated.

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
    59957
  • Event Risk Class
    Class 2
  • Event Number
    Z-0030-2012
  • Event Initiated Date
    2011-06-13
  • Event Date Posted
    2011-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104078
  • 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
    Fibrin split products - Product Code GHH
  • Reason
    There is a performance issue with minutex d-dimer kit which may cause false negative results for patient samples containing levels of greater than 250ng/ml d-dimer.
  • Action
    The firm,Tcoag US, Incorporated, sent an "Urgent Device Recall" letter dated June 13, 2011 via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products subject to recall; complete and return the attached Product Recall Notification Response Form by June 22, 2011 via fax at 973-775-3085; scrap the products consistent with their laboratory policy and if they have further distributed these products, notify their customers to quarantine and scrap the recalled product. For questions or technical assistance, please call the Tcoag hotline at 1-888-291-0415, option 2 (7.30 am to 6.00 pm Eastern Time).

Device

Device Recall Minutex DDimer
  • Model / Serial
    510 K number: K920668  Device listing number: D099358 Lot Numbers: Expiry Date: C040002 10 July 2012 C042002 14 Jan 2012 B218005 05 Jan 2012 B341002 03 May 2012 B144001 30 Sept 2011
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • Product Description
    Minutex D-Dimer ; Trinity Biotech plc, || Bray, || Co. Wicklow, || Ireland. || Tel: (353) 1 276 9800, || Fax: (353) 1 276 9888, || Web: www.trinitybiotech.com || Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.
  • Manufacturer
    Tcoag Us, Incorporated

Manufacturer

Tcoag Us, Incorporated
  • Manufacturer Address
    Tcoag Us, Incorporated, 330 Waterloo Valley Rd, Budd Lake NJ 07828-1395
  • Source
    USFDA