Events

Recall of Amplilink Software v3.2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Molecular Systems, 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
    62738
  • Event Risk Class
    Class 2
  • Event Number
    Z-2403-2012
  • Event Initiated Date
    2012-04-23
  • Event Date Posted
    2012-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111558
  • 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
    Blood establishment computer software, user developed - Product Code OYT
  • Reason
    When using a laboratory information system (lis) with automated systems utilizing amplilink software v3.2 series (al v3.2) there is a potential for wrong results to be assigned to an order.
  • Action
    Roche Molecular Systems Inc. sent "Urgent Field Safety Notice" letters and Faxback forms on 4/23/2012 via UPS to all affected customers. The issue was described and recommended actions were provided. A Product Advisory Notice and an Updated Field Safety Notice were issued as well.

Device

Amplilink Software v3.2
  • Model / Serial
    5666678001
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide (USA) Distribution
  • Product Description
    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA