Events

Recall of Device Recall OLA 2500 Olympus Lab Automation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus America, 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
    34058
  • Event Risk Class
    Class 3
  • Event Number
    Z-0322-06
  • Event Initiated Date
    2005-11-18
  • Event Date Posted
    2005-12-23
  • 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=43026
  • 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
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Reason
    Lab automation system may dilute samples with water.
  • Action
    Firm initiated recall on 11/18/05 via letter to all direct accounts.

Device

Device Recall OLA 2500 Olympus Lab Automation System
  • Model / Serial
    Serial Numbers: 93, 96, 112, 114, 1014 and 1054. Serial numbers correspond to units currently in distribution.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide; Distribution was made to laboratories and blood centers located in CA, CO, GA, NC, and OH.
  • Product Description
    OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.
  • Manufacturer
    Olympus America, Inc

Manufacturer

Olympus America, Inc
  • Manufacturer Address
    Olympus America, Inc, 3131 W Royal Ln, Irving TX 75063-3104
  • Source
    USFDA