Recall of Device Recall Roche Molecular Systems cobas 4800 System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    real time Nucleic acid amplification system - Product Code OOI
  • Reason
    Certain lots of reagent reservoirs, may not have a separation in the lower part of the reservoir. as a consequence, pipetting errors can occur due to uneven distribution of reagent. these pipetting errors may lead to delayed results and wasted reagent.
  • Action
    Roche sent a Urgent Medical Device Correction letter via UPS to all affected customers ( receipt required) The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to visually inspect affected product for the molding defect and to verify equal distribution of reagent in both chambers of the reservoir after adding reagent. All customers are requested to fill out the FAX Back form to schedule shipment of defective part. Non-responding accounts will be monitored on an ongoing basis and follow-up attempts will be made. Questions and concerns are to be addressed to Roche Molecular Diagnostics Technical Support 24 hours/day 1-800-526-1247.


  • Model / Serial
    Lot / SN : 477415,477416, 477898, and 477899
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.
  • Product Description
    Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.
  • Manufacturer


  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source