Events

Recall of Device Recall AMPLILINK Software, version 3.1.0 to 3.2.2

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
    52118
  • Event Risk Class
    Class 2
  • Event Number
    Z-1928-2009
  • Event Initiated Date
    2009-06-02
  • Event Date Posted
    2009-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82140
  • 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
    Clinical Sample Concentrator - Product Code JJH
  • Reason
    Software bug: a unique series of events involving the cobas ampliprep instrument running amplilink software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. the error can occur on either cobas ampliprep/cobas taqman 48, cobas ampliprep/cobas taqman (docked) or cobas s 201 system (docked) running amplilink software versions 3.1 or 3.2 series up to and.
  • Action
    Urgent Medical Device Correction Letters were sent on June 2, 2009 by first class mail. The letter described the issue; impact on results; clinical implications; the workaround; and the actions required, which include following the workaround until a new version of AMPLILINK software is available and filing the letter for future reference. Questions or concerns should be directed to Roche Diagnostics Technical Support at 1-800-526-1247.

Device

Device Recall AMPLILINK Software, version 3.1.0 to 3.2.2
  • Model / Serial
    Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. || Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.
  • 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