Events

Recall of Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 module

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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
    RC-2017-RN-00853-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00853-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Roche has identified that in very rare cases a sample mismatch may occur in specific immunochemistry modules. this issue can only occur if all 5 conditions below are met simultaneously.1. the immunochemistry module is included in its respective system (not standalone); and2. the “module rack buffer setting” ? 1; and3. one rack (rack a) is undergoing sampling and the following rack (rack b) is waiting for measurement; and4. the gripper (t/v carrier) fails to pick up the last vessel on rack a. as a result, the measurement for the sample in the last vessel which failed to be picked up is cancelled and the warning “tips/cup pick up error” (caution level) is issued; and5. sample position 1 of the following rack (rack b) is empty or has no test order for the immunochemistry module.This issue may be detected by 2 alarms occurring within a few minutes of one another: “tip/cup pick up error” (caution level)“abnormal l2-line movement” (s.Stop level).
  • Action
    Roche Diagnostics is requesting customers follow the detailed instructions given in the Customer Letter and to acknowledge receipt of the communication even if they have no stock which is subject to this recall action.

Device

Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 module
  • Model / Serial
    Various Immunochemistry modules. An in vitro diagnostic medical device (IVD)cobas e 601 moduleMaterial Number: 04745922001cobas e 602 moduleMaterial Number: 05990378001MODULAR ANALYTICS analyserMaterial Number: 03617505001MODULAR ANALYTICS EVO analyserMaterial Number: 04998642001All software versionsARTG Number: 173887
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited