Events

Recall of Device Recall CytoChex BCT

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

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
    76501
  • Event Risk Class
    Class 2
  • Event Number
    Z-1684-2017
  • Event Initiated Date
    2017-02-23
  • Event Date Posted
    2017-03-08
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153381
  • 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
    Tubes, vacuum sample, with anticoagulant - Product Code GIM
  • Reason
    Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.
  • Action
    On February 23, 2017, Streck electronically notified customers of the updated device correction. The recalling firm used an electronic mail alert to notify all of their customers the IFU for the recalled product had been revised. The specified the revision included phlebotomy guidelines specific to the 2.0 ml blood collections tubes. The revised IFU was provided as a link in the email. The recalling firm is reportedly able to monitor the access of the revised IFU to ensure each customer has received the information. For further questions, please call (402) 333-1982.

Device

Device Recall CytoChex BCT
  • Model / Serial
    UDI Number 10844509000836 and 20844509000833.  Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom. There was no military or government distribution.
  • Product Description
    Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.
  • Manufacturer
    Streck

Manufacturer

Streck
  • Manufacturer Address
    Streck, 7002 S 109th St, La Vista NE 68128-5729
  • Manufacturer Parent Company (2017)
    Streck Inc.
  • Source
    USFDA