Events

Recall of Device Recall Roche

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
    35493
  • Event Risk Class
    Class 2
  • Event Number
    Z-1176-06
  • Event Initiated Date
    2006-06-07
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46263
  • 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
    Cresolphthalein Complexone, Calcium - Product Code CIC
  • Reason
    Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling.
  • Action
    Consignees were notified via letter dated 6/6/06 and sent via UPS to discontinue use of these lots and to destroy them. Distributors are being asked to notify their customers.

Device

Device Recall Roche
  • Model / Serial
    Lots A157001 (exp. 7/31/07) and A157002 (exp. 9/30/07).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; Cat. No. 04585984160.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA