Events

Recall of ThromboMAX with Calcium

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trinity Biotech USA.

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
    30354
  • Event Risk Class
    Class 2
  • Event Number
    Z-0261-05
  • Event Initiated Date
    2004-10-27
  • Event Date Posted
    2004-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35722
  • 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
    Prolongation of prothrombin times in patient samples, resulting in a falsely elevated inr value.
  • Action
    Letters dated 11/1/2004 with instructions to (1) Discard remaining kits; (2) notify end-users; (3) Evaluate patient records when the kits were used to monitor Oral Anti-coagulant Therapy.

Device

ThromboMAX with Calcium
  • Model / Serial
    M13906, Exp. 6/14/06
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Trinity Biotech, Jamestown, NY sold product to 87 customers: 10 distributors (7 in U.S. & 3 foreign); 1 exporter; and 76 end users. 84 of those customers are located in the United States. There is one consignee in Canada, one in Brazil, and one in Venezuela. In addition, the manufacturer in Ireland sold additional units of this lot to other countries.
  • Product Description
    AMAX ThromboMAX with Calcium, 10x4ml vials. Catalog #T9902. Lyophilized extract of rabbit brain with buffer, stabilizers and calcium chloride. Responsible firm on the label: Trinity Biotech PLC, IDA Business Park, Bray, County Wicklow, Ireland. USA Enquiries - Trinity Biotech USA, 1930 Innerbelt Business Center Drive, St. Louis, MO 63114, USA.
  • Manufacturer
    Trinity Biotech USA

Manufacturer

Trinity Biotech USA
  • Manufacturer Address
    Trinity Biotech USA, 2823 Girts Rd, Jamestown NY 14701-9666
  • Source
    USFDA