Events

Recall of Device Recall COBAS Integra DIG

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
    37599
  • Event Risk Class
    Class 2
  • Event Number
    Z-0736-2007
  • Event Initiated Date
    2007-03-16
  • Event Date Posted
    2007-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50969
  • 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
    Digoxin Reagent - Product Code KXT
  • Reason
    The lower detection limit (ldl) may be a higher value than stated in the labeling. note: to resolve this issue, the digoxin ldl claim has been revised to 0.3 ng/ml for all reagent lots.
  • Action
    A recall letter dated 3/16/07 was sent to each consignee advising them that the LDL claim in the label has been revised to 0.3 ng/ml for all reagent lots.

Device

Device Recall COBAS Integra DIG
  • Model / Serial
    All Reagent Lots (including Lots 67941901, exp. 4/30/07; 68139201, exp. 6/30/07 and 68156201, exp. 8/31/07)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus, 700 and 800 analyzers, as well as, Cobas c 501 analyzer; Catalog Number 20737836322.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

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