Events

Recall of Glucose Hexokinase (Liquid) Reagent

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
    69622
  • Event Risk Class
    Class 2
  • Event Number
    Z-0827-2015
  • Event Initiated Date
    2014-10-23
  • Event Date Posted
    2014-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131170
  • 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
    Hexokinase, glucose - Product Code CFR
  • Reason
    Product is not performing according to specifications. control 2 does not consistently recover within its assigned range.
  • Action
    On October 23, 2014, JAS Diagnostics, Inc. sent out an IMPORTANT PRODUCT RECALL INFORMATION letter asking its consignees to discontinue use of the Glucose Hexokinase lots immediately. Customers are to contact the Service Department at 305-748-2762 or 305-748-2763 for information regarding reimbursement. Also, customers are to complete the attached Certificate of Destruction and return the document to JAS Diagnostics.

Device

Glucose Hexokinase (Liquid) Reagent
  • Model / Serial
    Lot: N0702011K, Exp. 10/2014; N0702012, Exp. 10/2014; N0702013K, Exp. 10/2014; P010201K, Exp. 04/2015; P010202K, Exp. 04/2015; P010203K, Exp. 04/2015; P010204K, Exp. 04/2015; P010205K, Exp. 04/2015; P010206K, Exp. 04/2015; P0402015K, Exp. 07/2015; P0402016K, Exp. 07/2015; P050207K, Exp. 08/2015; P050208K, Exp. 08/2015; P050209K, Exp. 08/2015; P0502010K, Exp. 08/2015; P0502011K, Exp. 08/2015; P0502012K, Exp. 08/2015; P0502013K, Exp. 08/2015; P0502014K, Exp. 08/2015; and P0802017K, Exp. 11/2015.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of NV, TN, TX, FL, GA, NY, NC, CA, MN, OR and Puerto Rico; and, the countries of France, Jamaica, Haiti, Cayman Islands, Trinidad & Tobago, and Ghana.
  • 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