Events

Recall of KWIK-QC ACID FAST STAIN SLIDE SL42-10

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

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
    110420
  • Event Risk Class
    II
  • Event Initiated Date
    2013-02-14
  • 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
    Mfg initiated the recall. the control organisms are not properly fixated on the slide which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. this contamination could potentially lead to misdiagnosis and improper treatment of a patient.

Device

KWIK-QC ACID FAST STAIN SLIDE SL42-10
  • Model / Serial
    Model Catalog: SL42-10 (Lot serial: 4242 EXP 2014/06/20); Model Catalog: SL42-10 (Lot serial: 4239 EXP MAY 12 2013); Model Catalog: SL42-10 (Lot serial: 4240 EXP NOV 1 2013); Model Catalog: SL42-10 (Lot serial: 4241 EXP FEB 13 2014); Model Catalog: SL42-10 (Lot serial: 4242 EXP JUN 20 2014); Model Catalog: SL42-10 (Lot serial: 4241 EXP 2014/02/13)
  • Product Description
    KWIK-QC ACID FAST STAIN SLIDES SL42-10
  • Manufacturer
    MICROBIOLOGICS INC.

Manufacturer

MICROBIOLOGICS INC.