Events

Recall of PICCOLO - COMPREHENSIVE METABOLIC PANEL

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

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
    75037
  • Event Risk Class
    II
  • Event Initiated Date
    2009-12-10
  • 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
    Bar code rings were mistakenly used in the manufacture of a small number of lot 9284ac2 cpomprehensive metabolic panel rotors at the very end of the manufacture run. this resulted in incorrect calibration factors being applied to the calculation of the measured values for serum creatinine on a sub-set of rotors. serum levels will be slightly lower.

Device

PICCOLO - COMPREHENSIVE METABOLIC PANEL
  • Model / Serial
    Model Catalog: 36 101 4431 (Lot serial: 9284AC2)
  • Product Description
    piccolo comprehensive metabolic panel
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC