Events

Recall of MULTIGENT CREATININE (ENZYMATIC)

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

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
    21297
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-06
  • 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
    Manufacturer detected a performance issue with the reagent 1 component. this issue may result in quality control values shifting out of acceptable range which is not resolved by recalibration. only replacement of the impacted lots with a new lot resolves the issue. in addition some customers have reported erratic patient results. manufacturer's investigation has determined that this issue is isolated to the 3 impacted lots.

Device

MULTIGENT CREATININE (ENZYMATIC)
  • Model / Serial
    Model Catalog: 8L24-31 (Lot serial: 60382Y600); Model Catalog: 8L24-41 (Lot serial: 60335Y600); Model Catalog: 8L24-31 (Lot serial: 60335Y600); Model Catalog: 8L24-31 (Lot serial: 60334Y600); Model Catalog: 8L24-41 (Lot serial: 60382Y600); Model Catalog: 8L24-41 (Lot serial: 60334Y600)
  • Product Description
    MULTIGENT CREATININE (ENZYMATIC)
  • Manufacturer
    SENTINEL CH. SPA

Manufacturer

SENTINEL CH. SPA
  • Manufacturer Address
    MILAN
  • Manufacturer Parent Company (2017)
    Sentinel Ch. Spa
  • Source
    HC