Events

Recall of Device Recall M53D Diluent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc. dba 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
    79556
  • Event Risk Class
    Class 2
  • Event Number
    Z-1321-2018
  • Event Initiated Date
    2018-01-24
  • 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=162631
  • 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
    Diluent, blood cell - Product Code GIF
  • Reason
    Certain lots of m-30d diluent used with bc-3200 and bc-3600 hematology analyzers and m-53d diluent used with bc-5390 hematology analyzer may cause the system to produce an elevated platelet background count.
  • Action
    Letters dated January 24, 2018, were sent to consignees with the following instructions: The issue manifests intermittently, therefore, you may continue to use affected lots if the background check is successfully completed. Discard affected lots which cause the system to display the error message background abnormal. Mindray will replace the potentially affected lots at no cost. Please contact Technical Support to order replacement product. For further questions, please call (201) 995-8407.

Device

Device Recall M53D Diluent
  • Model / Serial
    Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
  • Product Description
    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) || The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America