Events

Recall of Device Recall ACL ELITEPRO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumentation Laboratory Co..

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
    57274
  • Event Risk Class
    Class 2
  • Event Number
    Z-0807-2011
  • Event Initiated Date
    2010-11-11
  • Event Date Posted
    2010-12-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95726
  • 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
    Multipurpose System for In Vitro Coagulation Studies - Product Code JPA
  • Reason
    Sporadically lowered aptt results were observed with the pt/aptt test groups.
  • Action
    On 11/11/10, An Urgent Product Notification informing customers to discontinue use of all IL locked PT/APTT-based Test Groups was mailed to U.S. and Canadian customers, instructing them to run in Single Test or Profile Mode until further notice. The letter identified the affected product, the issue, risk and stated a list of mandatory actions. Customers are to immediately acknowledge the receipt of the notification by signing and returning it via email or fax. A Worldwide Regulatory Notice was sent on November 8, 2010 to international affiliates (non-U.S. or Canada), notifying them of the issue, providing a risk summary and the support documentation for the notification. Secondary international dealers were notified Nov 8 and a fax response of notification of the dealers will be tracked by International Laboratories. The customer notification of the secondary dealers will be handled per the local regulatory requirements of the countries where they are located.

Device

Device Recall ACL ELITEPRO
  • Model / Serial
    Serial numbers range 05010100 - 10111779.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United Arabian Emirates, Uruguay, Venezuela, Vietnam, Austria, Belgium, China, France, Germany, Holland, Italy, Japan, Spain (and Portugal), and UK.
  • Product Description
    ACL ELITE PRO Coagulation Analyzer, PN 00001000311 || Coagulation testing.
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • Manufacturer Address
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA