Events

Recall of Device Recall SPOTCHEM II Basic Panel test strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arkray Factory 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
    72860
  • Event Risk Class
    Class 1
  • Event Number
    Z-0631-2016
  • Event Initiated Date
    2015-12-18
  • Event Date Posted
    2016-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142374
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Reason
    One lot each of spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. the affected lots will display a result of approximately 300 to 400 mg/dl for any glucose value that exceeds the upper limit of 416 mg/dl.
  • Action
    The firm sent an Urgent Medical Device Recall letter to customers beginning 12/18/2015. The letter identified affected product, stated the reason for recall and asked for unused product to be returned. For instructions on returning unused product contact Lesty Jaranilla 1-877-538-8872 x3243.

Device

Device Recall SPOTCHEM II Basic Panel test strips
  • Model / Serial
    Lot Number PN5C26
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.
  • Product Description
    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. || For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.
  • Manufacturer
    Arkray Factory USA, Inc.

Manufacturer

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