Events

Recall of Device Recall cobas p 512 preanalytical 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
    Recall
  • Event ID
    73292
  • Event Risk Class
    Class 2
  • Event Number
    Z-1233-2016
  • Event Initiated Date
    2016-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143776
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Due to a false triggering or detection of the lifting gripper ready signal, sample tubes are not correctly placed back in the rack tube transport (rtt) after the decapping process. therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
  • Action
    Roche Diagnostics sent an "Urgent Medical Device Correction" letter via UPS Ground (receipt required) on February 23, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To prevent this malfunction, a software patch has been developed and validated. The installation of this software patch is mandatory and will be performed by a Roche Field Engineering Specialist (FES). Your Roche FES will contact you to schedule the installation of the software patch. Until the software patch is implemented, Roche recommends that instrument operators monitor their systems for the occurrence of Error 140 Gripper has lost tube. If this error occurs, all components in contact with a spill must have extra cleaning. Refer to the cobas p 512 pre-analytical instrument Operators Manual Version 1.5. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 for further questions.

Device

Device Recall cobas p 512 preanalytical system
  • Model / Serial
    Part numbers:05083435001 and 06268854001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
  • Product Description
    cobas p 512 pre-analytical system || Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

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