Events

Recall of One Touch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Core Care Technologies, 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
    36863
  • Event Risk Class
    Class 1
  • Event Number
    Z-0266-2007
  • Event Initiated Date
    2006-10-14
  • Event Date Posted
    2007-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49472
  • 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
    Blood Glucose Test Strips - Product Code NBW
  • Reason
    Counterfeit product (manufacturer unknown).
  • Action
    The firm identified the customers who had been sent OneTouch test strips since August 2006 and contacted each by phone to identify the lot number of the test strips in the customer's possession. A letter was sent on 11/21/2006 by first class mail which identified the lot numbers identified in the letter from the law firm and providing instructions to follow if the affected lots were found.

Device

One Touch

Manufacturer

Core Care Technologies, Inc
  • Manufacturer Address
    Core Care Technologies, Inc, 309 Fries Mill Rd., Suite 14, Sewell NJ 08080
  • Source
    USFDA