Events

Recall of Device Recall cobas Liat Influenza A/B Quality Control Kit

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
    74154
  • Event Risk Class
    Class 3
  • Event Number
    Z-2203-2016
  • Event Initiated Date
    2016-05-17
  • Event Date Posted
    2016-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146524
  • 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
    Kit labeled with the incorrect expiration date.
  • Action
    An Urgent Medical Device Recall (UMDR) notice (Customer Letter) was sent to the 35 individual affected customer sites by UPS on May 17 2016. Customers were asked to take the following actions: " Discontinue use of cobas¿ Liat Influenza A/B Quality Control kit lot numbers 51222E, 60121H, 60201D, and 60229F, and discard them per your local regulations. " Complete the enclosed UMDC faxback form (6941-00-0516) and fax it to 1-844-449-8506. " File this UMDC for future reference.

Device

Device Recall cobas Liat Influenza A/B Quality Control Kit
  • Model / Serial
    Lot Numbers: 51222E, 60121H, 60201D, and 60229F
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
  • Product Description
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
  • 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