Events

Recall of Device Recall Thromboelastograph Instrument

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Haemonetics 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
    65635
  • Event Risk Class
    Class 2
  • Event Number
    Z-1796-2013
  • Event Initiated Date
    2013-06-20
  • Event Date Posted
    2013-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119790
  • 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
    Research use only (ruo) parameters were included in teg 5000 user manual.
  • Action
    Haemonetics sent a Medical Device Correction letter dated June 20, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. The letter instructs customers to discard the current manuals and replace with revised manuals included with the Customer Notification Letter. A Consignee Response Form has been included with the letter, which is to be signed and returned for effectiveness purposes. Follow up will be made to customers who don't return the Response Form. For questions contact TEG Technical Support team at 1-800-438-2834.

Device

Device Recall Thromboelastograph Instrument
  • Model / Serial
    Per recall strategy.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide
  • Product Description
    TEG 5000 Thromboelastograph Coagulation Analyzer || Product Usage: || Multipurpose System for In Vitro Coagulation Studies
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Manufacturer Address
    Haemonetics Corporation, 400 Wood Road, Braintree MA 02184-2412
  • Manufacturer Parent Company (2017)
    Haemonetics Corporation
  • Source
    USFDA