Events

Recall of Device Recall Coaguchek

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Corp..

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
    37602
  • Event Risk Class
    Class 2
  • Event Number
    Z-0737-2007
  • Event Initiated Date
    2007-02-28
  • Event Date Posted
    2007-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50981
  • 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
    PLASMA, COAGULATION CONTROL , TEST STRIPS - Product Code GJS
  • Reason
    The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
  • Action
    All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.

Device

Device Recall Coaguchek
  • Model / Serial
    Lots 469A and 475A; exp. 6/30/2008.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
  • Product Description
    CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
  • Source
    USFDA