Events

Recall of Device Recall Amplilink

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
    37963
  • Event Risk Class
    Class 2
  • Event Number
    Z-1107-2007
  • Event Initiated Date
    2007-05-21
  • Event Date Posted
    2007-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52496
  • 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
    in vitro diagnostic - Product Code MZP
  • Reason
    For select cobas amplicor tests run on the cobas amplicor analyzer in conjunction with amplilink software, a discrepancy has been identified between the onboard working reagent stability information reported by amplilink software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.
  • Action
    Urgent Medical Device Correction letters were mailed on 5/21/07 by first class mail. Letters describe the discrepancy between software reagent expiration dates and package insert expiration dates.

Device

Device Recall Amplilink
  • Model / Serial
    Catalog number 03576710190, working substrate SB3-SB
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide to hospitals and laboratories.
  • Product Description
    Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 || COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA