Events

Recall of Device Recall QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quantimetrix Corporation.

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
    48190
  • Event Risk Class
    Class 2
  • Event Number
    Z-0513-2009
  • Event Initiated Date
    2007-06-01
  • Event Date Posted
    2009-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70967
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
  • Action
    The recall communication was initiated when customer both direct and distributors who have purchased the lots were mailed a recall notification letter dated June 8, 2008 with instructions which was sent via first class mail. Customers were requested to assist in the voluntary recall of the listed product and if any of the affected lots have been consumed please review their records to ensure that the obtained values conform to the stated specifications found in the lot specific product insert.

Device

Device Recall QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL
  • Model / Serial
    Lot Number: 48170, 48171, 48172, 48180, 48181 and 48182.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.
  • Product Description
    Quantimetrix QuanTscopics Urine Microscopics Control. || QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.
  • Manufacturer
    Quantimetrix Corporation

Manufacturer

Quantimetrix Corporation
  • Manufacturer Address
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • Manufacturer Parent Company (2017)
    Quantimetrix Corporation
  • Source
    USFDA