Events

Recall of ELECSYS TOTAL PSA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS.

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
    104277
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-06
  • 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
    There is a reduced onboard stability for the 100 tests kit size with the afp application file version 104 and tpsa application file version 103. the onboard stability of the 100 tests kit was harmonized with the 200 tests kit to the stability claim of (28 days) to allow the use of both reagent kit sizes in parallel on the cobas e 602 with the new software version 04-01. ^.

Device

ELECSYS TOTAL PSA
  • Model / Serial
    Model Catalog: 04641655190 (Lot serial: All lots); Model Catalog: 04491742190 (Lot serial: All lots); Model Catalog: 04481798190 (Lot serial: All lots)
  • Product Description
    Elecsys total PSA
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Manufacturer Address
    LAVAL
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC