Events

Recall of ROTROL P

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TEM Systems 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
    70690
  • Event Risk Class
    Class 2
  • Event Number
    Z-1379-2015
  • Event Initiated Date
    2014-10-23
  • Event Date Posted
    2015-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134494
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Reason
    Some of vials were found to be partially filled.
  • Action
    Tem sent an Dear Customer letter dated October 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are entitled to return products delivered to you in the event that they are defective or otherwise not in conformity with your order when you received them. If you observe a low level of diluent in a box of Rotrol P lot number 41819801 at your location, please contact us for a free of charge replacement box from a new lot of Rotrol P. You can reach us at: Email: support@roteminc.com Phone: 919-941-7777, Option 2 Toll Free: 1-866-597-1652, Option 2 We apologize for any inconvenience you may experience.

Device

ROTROL P
  • Model / Serial
    Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
  • Manufacturer
    TEM Systems Inc

Manufacturer

TEM Systems Inc
  • Manufacturer Address
    TEM Systems Inc, 4309 Emperor Blvd Ste 100, Durham NC 27703-8069
  • Source
    USFDA