Events

Recall of Roche PTH

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
    37761
  • Event Risk Class
    Class 2
  • Event Number
    Z-0810-2007
  • Event Initiated Date
    2007-04-19
  • Event Date Posted
    2007-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51475
  • 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
    in vitro diagnostic - Product Code CEW
  • Reason
    Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.
  • Action
    The firm issued a letter dated 04/19/07 to all users informing them of the change in the hemoglobin interference claim.

Device

Roche PTH
  • Model / Serial
    Lots 17723501, exp. 1/31/08; 17723502, exp. 1/31/08; 17642601, exp. 11/30/07; 17642602, exp. 11/30/07; 17450901, exp. 5/31/07; 17450902, exp. 5/31/07 and 17450903, exp. 5/31/07.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

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