Events

Recall of Device Recall DiaScreen Reagent Strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ARKRAY USA 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
    55680
  • Event Risk Class
    Class 3
  • Event Number
    Z-2634-2010
  • Event Initiated Date
    2010-03-24
  • Event Date Posted
    2010-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91552
  • 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
    Urine Leukocyte test - Product Code LJX
  • Reason
    This recall has been initiated due to a labeling issue with the hypoguard diascreen 4-way ph 100 strips. the front and back panel of the bottle carton lists five reagents when it should only list four reagents. the ketone reagent should not be included on the label. the test strips contained in the bottle and all other labeling are correct and properly align with 4ph part number d11400 listed on.
  • Action
    Distributors were sent a Arkray "URGENT: Voluntary Medical Device RECALL " letter dated March 24, 2010. The letter described the problem and the product being recalled. The letter requested the distributors to immediately examine their inventory , quarantine and return the product subject to the recall. If the distributors had further distributed the recalled product, then they were requested to notify the customers of the recall. Arkray enclosed a customer recall letter that the distributors were to use for notifying their customers. Distributors were also contacted by phone on March 24, 2010, and were informed of the recall issue, the product involved, instructed to quarantine the product and to notify their customers.

Device

Device Recall DiaScreen Reagent Strips
  • Model / Serial
    03269A, 06089A, 10079A and 11099A
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, IL ISRAEL
  • Product Description
    Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
  • Manufacturer
    ARKRAY USA INC.

Manufacturer

ARKRAY USA INC.
  • Manufacturer Address
    ARKRAY USA INC., 5182 W 76th St, Minneapolis MN 55439-2900
  • Manufacturer Parent Company (2017)
    Arkray Global Business Inc.
  • Source
    USFDA