Events

Recall of Device Recall Cobas 8100 unidirectional reformatter (URF)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Corporation.

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
    76628
  • Event Risk Class
    Class 2
  • Event Number
    Z-1764-2017
  • Event Initiated Date
    2017-03-01
  • Event Date Posted
    2017-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153704
  • 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
    Roche diagnostics corp. initiated a voluntary correction because a rack crash may occur on the cobas 8100 bi-directional reformatter (brf) and uni-directional reformatter (brf) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. this issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over.
  • Action
    Roche initiated a recall on 03/01/2017, notices were issued via UPS to customers and instructed customers to do the following: Roche is developing software version 03-01 to resolve this issue, and a Roche Representative will be contacting you in the near future to schedule an update. Until this software update is available, the rack buffering option for the BRF and URF modules must be disabled. If you are an authorized cobas 8100 automated workflow series operator, follow the steps outlined below to disable rack buffering. If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. If you have a major spill, set the affected module to offline and contact the Roche Support Network Customer Support Center at 1-800-428-2336. " If you are an authorized cobas¿ 8100 automated workflow series operator, follow the steps outlined in this Urgent Medical Device Correction (UMDC) to disable rack buffering. " If your facility does not have an authorized cobas 8100 automated workflow series operator, please contact the Roche Support Network Customer Support Center at 1-800-428-2336 for further steps. " Complete the attached faxback form and fax it to 1-888-345-0024. " File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Device

Device Recall Cobas 8100 unidirectional reformatter (URF)
  • Model / Serial
    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx  Catalog Number: URF module: 07441657001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Domestic: MA, IN, AL, OH, MO, NE, LA, CA, IA, NJ, AR, PA, SC, IL, TX, and MI. Foreign: None
  • Product Description
    Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
  • Manufacturer
    Roche Diagnostics Corporation

Manufacturer

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