Events

Recall of COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V3.0.35

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE MOLECULAR SYSTEMS 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
    70567
  • Event Risk Class
    III
  • Event Initiated Date
    2015-04-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The pooling software can create pools containing more or less donors than originally intended during simultaneous pooling runs for both the cobas taqscreen mpx and cobas taqscreen wnv tests when the donor tube carrier on the hamilton star/starlet pipettor is missing a donor tube in any position within the donor tube carrier.

Device

COBAS S201 SYSTEM POOLING AND DATA MANAGEMENT (PDM) V3.0.35
  • Model / Serial
    Model Catalog: 06660975190 (Lot serial: All lots)
  • Product Description
    Cobas s201 System Pooling and data management (PDM) V3.0.35
  • Manufacturer
    ROCHE MOLECULAR SYSTEMS INC

Manufacturer

ROCHE MOLECULAR SYSTEMS INC
  • Manufacturer Address
    BRANCHBURG
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC