Events

Recall of MICROSCAN NEG BP COMBO PANEL

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
    53867
  • Event Risk Class
    III
  • Event Initiated Date
    2014-08-14
  • 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 technical suppot bulletin (tsb-190) provided instructions for creating new labpro ast interpretation action alert rules to enable reporting of the new enterobacteriaceae breakpoints on microscan dried gram negative mic/combo panel types containing the lower imipenem (imp) dilutions. however the tsb did not mention the performance limitation for the enterobacteria proteus mirabilis and imipenem for which the revised interpretive criteria may result in minor errors with clinical p. mirabilis isolates. therefore the drug name minimal inhibitory concentration (mic) and interpretation should not be reported for p. mirabilis and imp on the microscan dried gram negative mic/combo panels listed in (1).

Device

MICROSCAN NEG BP COMBO PANEL
  • Model / Serial
    Model Catalog: B1017-417 (Lot serial: >100 numbers contact mfg); Model Catalog: B1017-412 (Lot serial: >100 numbers contact mfg); Model Catalog: B1027-101 (Lot serial: >10 numbers contact mfg); Model Catalog: B1017-407 (Lot serial: >1000 numbers contact mfg); Model Catalog: B1017-409 (Lot serial: >1000 numbers contact mfg); Model Catalog: B1017-414 (Lot serial: >1000 numbers contact mfg)
  • Product Description
    Microscan NEG bp cOMBO pANEL
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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