Events

Recall of Device Recall BS200 Chemistry Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc. d.b.a. Mindray North America.

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
    64112
  • Event Risk Class
    Class 2
  • Event Number
    Z-0977-2013
  • Event Initiated Date
    2012-11-28
  • Event Date Posted
    2013-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115382
  • 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
    Hexokinase, glucose - Product Code CFR
  • Reason
    An issue has been identified with the bs-200 where clinical chemistry results may be inaccurate.
  • Action
    Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge.

Device

Device Recall BS200 Chemistry Analyzer

Manufacturer

Mindray DS USA, Inc. d.b.a. Mindray North America