Events

Recall of Bayer Advia 70 Hematology Analyzer

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

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
    36728
  • Event Risk Class
    Class 2
  • Event Number
    Z-0450-2007
  • Event Initiated Date
    2006-09-20
  • Event Date Posted
    2007-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49230
  • 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 Analyzer - Product Code GKZ
  • Reason
    System has given inaccurate readings when running samples that trigger an extra rinse due to very high wbc, rbc or platlet counts.
  • Action
    Firm sent 'Technical Bulletin #39' to all customers on 09/20/06. Users advised of potential for inaccurate readings and provided with instructions on how to eliminate problem.

Device

Bayer Advia 70 Hematology Analyzer
  • Model / Serial
    All lots.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including USA states of FL, MA, MN, ND, NM, NY, Puerto Rico and TX and countries of Austria, Bangladesh, Chile, China, Czech Republic, Egypt, France, Hong Kong, Italy, India, Iran, Korea, Mexico, Morocco, Phillipines, Portugal, Russia, Serbia and Montenegro, Spain, Syria, Thailand, Turkey, United Arab Emerates (Dubai), United Kingdom and Vietnam, West Indies and Yemen.
  • Product Description
    Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.
  • Manufacturer
    Drew Scientific Group PLC

Manufacturer

Drew Scientific Group PLC
  • Manufacturer Address
    Drew Scientific Group PLC, 4230 Shilling Way, Dallas TX 75237-1023
  • Source
    USFDA