Events

Recall of Device Recall MicroScan LabPro Information Manager System

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

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
    71819
  • Event Risk Class
    Class 2
  • Event Number
    Z-2809-2015
  • Event Initiated Date
    2015-07-17
  • Event Date Posted
    2015-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139149
  • 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
    Medical device data system - Product Code OUG
  • Reason
    The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an id hold status.
  • Action
    An Urgent Medical Device Recall Letter dated 7/17/2015 was sent to all customers who purchased the MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11. Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Customer Support Representative: http:www.beckmancoulter.com, (800) 677-7226 in US and Canada. Customers outside of US and Canada, are instructed to contact their local Beckman Coulter representative.

Device

Device Recall MicroScan LabPro Information Manager System
  • Model / Serial
    Version 1.0 to Version 4.11
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: United States (including Puerto Rico), Bahamas, Belgium, Canada, Chile, China, Colombia, France, French Guiana, Germany, Greece, Guadeloupe, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Turkey, , US Virgin Islands, and Northern Mariana Islands, Uruguay.
  • Product Description
    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA