Safety Alert for SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Arkray Factory Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: arkray factory inc spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip the united states food and drug administration (fda) has issued an alert concerning the spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip [lot numbers: pn5c26 and ea4m78; manufacturing dates: november 2014 to september 2015; distribution dates: 18 february 2015 to 13 october 2015], manufactured by arkray factory inc. according to the fda, the manufacturer is recalling the spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip because they may report falsely low blood glucose levels when the true levels are above 265 mg/dl. there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in a timely manner and fail to treat elevated blood glucose levels. the issue may cause serious injury or death. the manufacturer sent an urgent medical device recall letter to customers in the united states beginning on 18 december 2015. the letter identified affected product, stated the reason for recall and provided instructions for returning unused product to the firm. tfor details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=72867&w=01202016%e2%8c%a9=eng http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm483792.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm483760.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 january 2016.