Events

Safety Alert for loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-05-26
  • Event Date Posted
    2014-05-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140526.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: roche loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602 medical device manufacturer, roche, has issued a field safety notice (fsn) concerning roche loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602. based on recently received complaints, the manufacturer has identified that under certain conditions loose procell /cleancell aspiration tube filters might affect results. when the procell / cleancell bottle is almost empty (the liquid level in the procell / cleancell bottle drops below the joint between aspiration tube and the filter), system reagent foam may be created and aspirated into the measuring cell. in case of procell this can cause discrepant results: high for competitive and low for sandwich assays. the magnitude of the discrepancy varies with the amount of air being aspirated. the manufacturer advises users of the followings: special caution should be taken so that the aspiration tube lifter is not dropped after the replacement of the procell / cleancell bottle. users should check that the procell /cleancell aspiration tube filter is properly tightened. if the procell / cleancell aspiration tube filter is blocked and needs to be cleaned, users should ensure that the filter is properly tighten when placing it back after the cleaning process. there will be a change of the “procell / cleancell aspiration tube filter check” from operator’s maintenance to service maintenance. the operator’s manual will be updated accordingly. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 may 2014.

Device

loose procell / cleancell aspiration tube filter on modular analytics , cobas e601 and cobas e602
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche Loose ProCell / CleanCell Aspiration Tube Filter on MODULAR ANALYTICS , cobas e601 and cobas e602
  • Manufacturer
    Roche

Manufacturer

Roche