Events

Recall of Device Recall cobas Liat Analyzer

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
    71785
  • Event Risk Class
    Class 2
  • Event Number
    Z-2543-2015
  • Event Initiated Date
    2015-07-24
  • Event Date Posted
    2015-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139100
  • 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
    Respiratory virus panel nucleic acid assay system - Product Code OCC
  • Reason
    Due to a supplier issue, the incorrect green and amber led components were used in the manufacture of the led printed circuit board assemblies (pcba) in certain cobas liat analyzers.
  • Action
    Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Actions Required Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1. You will be contacted to return affected systems for immediate replacement. Complete the attached fax form and fax it to 1-317-521-4815. File this UMDR for future reference. Please contact the Roche Support Network Customer Support Center cobas¿ Liat hotline at 1-800-800-5973, if you have questions about the information contained in this letter.

Device

Device Recall cobas Liat Analyzer
  • Model / Serial
    Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of :TX and NC.
  • Product Description
    cobas Liat Analyzer, for in vitro diagnostic use.
  • 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