Events

Recall of Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Haemoscope Division of Haemonetics Corp.

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
    58847
  • Event Risk Class
    Class 2
  • Event Number
    Z-2742-2011
  • Event Initiated Date
    2011-03-04
  • Event Date Posted
    2011-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100407
  • 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
    Hematology Multipurpose System for In Vitro Coagulation Studies - Product Code JPA
  • Reason
    Haemoscope received a report that during the process of validation, level ii qc was running with an out-of-range low ma (maximum amplitude).
  • Action
    Haemoscope, a Division of Haemonetics Corp, sent a letter dated March 2, 2011 to all of the affected customers. The letters informed the customers that Haemoscope had received a higher than normal inquiry rate for the Level II Quality Control Kits, part 07-008, lots HMO196 and HMO 197. The accounts were requested to return their stocks of those two lots for further testing and evaluation and to complete the enclosed acknowledgement form, confirming receipt of the letter and the number of kit boxes being returned, and fax it back to Haemoscope at 847-588-0455. The returned kits will be replaced at no charge. For additional information please contact Haemoscope at 847-588-0453, ext-217 .

Device

Device Recall TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit
  • Model / Serial
    part number 07-008, catalog number REF 8002, lot numbers HMO196 and HMO197, expiration date July 2011
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide and the countries of Canada, Czech Republic and the Philippines
  • Product Description
    TEG Hemostasis System Level II Control: || Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series || Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
  • Manufacturer
    Haemoscope Division of Haemonetics Corp

Manufacturer

Haemoscope Division of Haemonetics Corp
  • Manufacturer Address
    Haemoscope Division of Haemonetics Corp, 6231 W Howard St, Niles IL 60714-3403
  • Manufacturer Parent Company (2017)
    Haemonetics Corporation
  • Source
    USFDA