Events

Recall of Roche COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL)

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
    63814
  • Event Risk Class
    Class 2
  • Event Number
    Z-0614-2013
  • Event Initiated Date
    2012-10-11
  • Event Date Posted
    2012-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114824
  • 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
    Certain cobas ampliprep instruments using ampilink software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.
  • Action
    Roche sent an Urgent Medical Device Correction notification/Fax Back forms dated 10/11/12 to potentially affected customers. The letter identified the affected product, the issue, clinical significance, workaround, and required actions, along with contact information. Customers are to use the workaround until their Roche FSE has performed a Master Initialization on their affected instruments. Also, the letter should be filed for future reference. Questions should be directed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.

Device

Roche COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL)
  • Model / Serial
    CAP 394436 to 394663
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of GA, CA, NC, and MN.
  • Product Description
    COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 || Automated sample processing instrument used with CAP/CA and CAP/CTM. || Roche Molecular Systems, Inc. || 1080 US Highway 202 South || Branchburg, NJ 08876 || USA || Made in Switzerland
  • 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