Events

Recall of Device Recall Cobas connection module (CCM) OUTPUT UNIT

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
    77243
  • Event Risk Class
    Class 2
  • Event Number
    Z-2223-2017
  • Event Initiated Date
    2017-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155542
  • 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
    A gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. this issue can pose a potential risk to involved operators and can also lead to potential cross contamination of samples in the affected racks.
  • Action
    Roche sent an Urgent Medical Device Correction letter dated May 9, 2017, to all affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Consignees were asked to complete the attached form and fax it to 877-906-8982 or email to Indianapolis.cd_tsc@roche.com. Consignees with questions were instructed to contact the Roche Support Network Customer Support Center at 1-800-428-2336.

Device

Device Recall Cobas connection module (CCM) OUTPUT UNIT
  • Model / Serial
    Serial Number 204C5690 204H0157 204H0158
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US distribution to WA only.
  • Product Description
    Cobas connection module (CCM) - OUTPUT UNIT || The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system
  • 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