Events

Recall of Device Recall Integra

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
    31056
  • Event Risk Class
    Class 3
  • Event Number
    Z-0649-05
  • Event Initiated Date
    2005-02-15
  • Event Date Posted
    2005-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37073
  • 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
    Assay, Glycosylated Hemoglobin - Product Code LCP
  • Reason
    The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
  • Action
    Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.

Device

Device Recall Integra
  • Model / Serial
    Lots 660587, 659867, 657295, 657344, 658498, 656157, 655052, 653288, 653424, 652153, 650988, 650430, 650119, 649291, 647186, 646336, 644962, 643398 and 642104.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

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