Events

Recall of Device Recall Roche cobas

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
    63310
  • Event Risk Class
    Class 3
  • Event Number
    Z-0188-2013
  • Event Initiated Date
    2012-07-31
  • Event Date Posted
    2012-11-02
  • 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=113477
  • 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
    Somatic gene mutation detection system - Product Code OWD
  • Reason
    It was identified that braf controls dispositioned as "internal use only" were incorrectly packaged into cobas 4800 braf v600 mutation test ce-ivd kit lot r03607 and released for distribution. two control batches manufactured during two process validation studies are involved: pv7711: braf mutant (mut) control pv0853: braf wild type (wt) control.
  • Action
    Roche sent a Safety Board Notice - Product Bulletin 2012-013 on 31-Jul-2012 to affected customers. The notice identifed the affected product, description of situation and actios to be taken. Customers were instructed to discontinue use, quarantine and discard any remaining kits of the affected product in inventory. Customers were advised to contact their affiliate sales office for replacement. The notice states a new cobas 4800 BRAF V600 Mutation Test lot (R07749) is anticipated to be available on 03-Aug-2012. For questions call +01.908.253.7569.

Device

Device Recall Roche cobas
  • Model / Serial
    Material number 05985595190; Lot number R03607
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
  • Product Description
    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., || Product Usage: || The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
  • 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