Events

Recall of Device Recall Remel QCSlide Gram Stain Control

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel, 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
    27713
  • Event Risk Class
    Class 2
  • Event Number
    Z-0273-04
  • Event Initiated Date
    2003-11-03
  • Event Date Posted
    2003-12-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30394
  • 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
    Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area.
  • Action
    Letters dated 10/29/03 were issued via regular mail on 11/3/03 requesting the customer to discard remaining inventory of the lot.

Device

Device Recall Remel QCSlide Gram Stain Control
  • Model / Serial
    Lot #001453, Exp. 2013-04-03
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities, laboratories, and military facilities located in NY, MN, PA, VA, MI, NM, RI, IN, MA, WI, CT, OH, and NC.
  • Product Description
    Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box. The responsible firm on the label is Remel, Lenexa, KS.
  • Manufacturer
    Remel, Inc.

Manufacturer

Remel, Inc.
  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA