Events

Recall of Device Recall Microbiologics KWIKQC SLIDES

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    64469
  • Event Risk Class
    Class 2
  • Event Number
    Z-1021-2013
  • Event Initiated Date
    2013-02-11
  • Event Date Posted
    2013-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116205
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Quality control slides - Product Code LJG
  • Reason
    Microbiologics inc is initiating a voluntary recall on products kwik-qc acid fast stain slide, sl42-10 and kwik-qc mycobacterium, sl43-10. these products are being recalled because 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 pote.
  • Action
    Microbiologists an "Urgent Medical Device Recall" letter dated February 11, 2013. The Letter described the product and the reason for the recall. Advised consignees to "Do not Distribute" and "Return" the product. Urged consignees to "Notify" end users and to complete the attached "Recall Response Form". Contact the form at 320-229-7057 for questions regarding this notice.

Device

Device Recall Microbiologics KWIKQC SLIDES
  • Model / Serial
    SL42-10 Lots 4239 to 4243 SL43-10 Lots 4333 to 4337
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of CA, IN, MS, NY, OH, PA, and SD, and the countries of AUSTRALIA, AUSTRIA, UNITED ARAB EMIRATES, MALAYSIA, TAIWAN, JAPAN, TURKEY, BELGIUM, COLOMBIA, CANADA, SOUTH AFRICA, and VENEZUELA.
  • Product Description
    Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). || Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents.
  • Manufacturer
    Microbiologics Inc

Manufacturer

Microbiologics Inc
  • Manufacturer Address
    Microbiologics Inc, 200 Cooper Avenue North, Saint Cloud MN 56303-4452
  • Manufacturer Parent Company (2017)
    Microbiologics Inc
  • Source
    USFDA