Events

Recall of JAS Diagnostics Inc., SDI Biomed, Drew Scientific, and ETron Diagnostics

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by JAS Diagnostics 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
    68343
  • Event Risk Class
    Class 2
  • Event Number
    Z-1873-2014
  • Event Initiated Date
    2014-04-07
  • Event Date Posted
    2014-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127383
  • 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
    Jas diagnostics, inc. of miami lakes, fl is recalling their glucose hexokinase reagent due to certain lots not performing according to their specifications.
  • Action
    JAS Diagnostics, Inc. sent an Important Product Recall Information letter dated April 7, 2014 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1) Screen their inventory for any of the lots listed in the letter and discontinue use immediately. 2) Contact the Customer Service Department at 305-748-2762 or 305-748-2763 to obtain replacement product.

Device

JAS Diagnostics Inc., SDI Biomed, Drew Scientific, and ETron Diagnostics
  • Model / Serial
    LOTS#: N060208K, N060209K, N0602010K, N0902014K, N0902015K, N0902016K, N0902017K, N0902018K, N0902019K, N0902020K, N1102021K, N1102022K, N1102023K, N1102024K, N1102025K, N1102026K, N1102027K, N1102028K, N1102029K.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including Puerto Rico and the states of CA, FL, TX, PA, GA, KY, MI, NY, OK, MN, TN, VA, NC, NV, NJ and WV, and the countries of Barbados, Ghana, Trinidad, Tobago, Canada and Haiti.
  • Product Description
    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
  • Manufacturer
    JAS Diagnostics Inc.

Manufacturer

JAS Diagnostics Inc.
  • Manufacturer Address
    JAS Diagnostics Inc., 14100 Nw 57th Ct, Miami Lakes FL 33014-3107
  • Manufacturer Parent Company (2017)
    Transasia Bio-Medicals Limited
  • Source
    USFDA