Events

Recall of Device Recall TEG Haemonetics System Level II Control

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
    70352
  • Event Risk Class
    Class 2
  • Event Number
    Z-1130-2015
  • Event Initiated Date
    2015-01-26
  • Event Date Posted
    2015-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133242
  • 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
    Specific lots of level ii control kits produce high maximum amplitude (ma) results, which are outside of the manufacturer's expected quality control range for ma parameter.
  • Action
    Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.

Device

Device Recall TEG Haemonetics System Level II Control
  • Model / Serial
    Lot numbers: HMO 9200  HMO 9217  HMO 9226  HMO 9232  HMO 9276  HMO 9285  HMO 9292 Exp. Date 1/2017
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
  • Product Description
    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. || Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

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