Events

Recall of SYNERGIES PLUS NEG

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

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
    107149
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-26
  • 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
    A carbapenemase producing enterobacteriacae (cre) reported false susceptible with the carbapenem imipenem. the instrument rapid read (<16 hours) reported imipenem of <4 ?g/ml on a synergies plus negative panel and after overnight incubation imipenem was resistant (>8) by visual examination. this results in a categorical very major error (vme).

Device

SYNERGIES PLUS NEG
  • Model / Serial
    Model Catalog: B1025-106 (Lot serial: JUNE 2011 AND AUGUST 2013); Model Catalog: B1025-106 (Lot serial: ALL LOTS SHIPPED BETWEEN)
  • Product Description
    SYNERGIES PLUS NEG
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC