Events

Recall of Device Recall SYNOVIALSCOPICS, SYNOVIAL FLUID 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-0516-2009
  • 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=70970
  • 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
    Mixture, hematology quality control - Product Code JPK
  • 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 SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
  • Model / Serial
    Lot Numbers: 38050 and 38060.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • 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 Synovialscopics Synovial Fluid Control. || Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation.
  • 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