Events

Recall of VERSATREK 240 SYSTEM - INSTRUMENT

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

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
    21538
  • Event Risk Class
    III
  • Event Initiated Date
    2015-06-12
  • 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
    An internal investigation has shown that the use of the versatrek automated microbial detection system might result in false positive reports. to date three (3) customer complaints have been received all in conjunction with versatrek myco bottle usage. review of instrument databases suggests that on rare occasions the barometric pressure readings may be inconsistent. this event is caused by a protective sticker covering the sensor. if this sticker forms a complete seal it traps air under the sticker resulting in incorrect atmospheric pressure readings. this in turn leads to reports of false positives.

Device

VERSATREK 240 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 6240-04 (Lot serial: 2208X1113); Model Catalog: 6528-22 (Lot serial: 2298X0714)
  • Product Description
    VERSATREK AUTOMATED MICROBIAL DETECTION SYSTEM (240 MODEL)
  • Manufacturer
    OXOID COMPANY

Manufacturer

OXOID COMPANY