Events

Recall of Device Recall COBAS

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

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
    29358
  • Event Risk Class
    Class 1
  • Event Number
    Z-1119-04
  • Event Initiated Date
    2004-05-24
  • Event Date Posted
    2004-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33590
  • 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
    Analyzer, Chemistry, Micro, For Clinical Use - Product Code JJF
  • Reason
    Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
  • Action
    An Urgent Product Recall letter was sent to all customers with a COBAS TaqMan 96 and 48 analyzer on 5/24/2004 by overnight delivery with delivery confirmation. On May 25, 2004, All Roche Field Service Engineers were instructed to inspect the analyzers to confirm that the cables were properly seated.

Device

Device Recall COBAS
  • Model / Serial
    COBAS TaqMan Analyzer Serial Numbers: 381046; 381053; 391159; 391166; 391181; 371036; 391130; 391095; 381052; 391191; 391096; 381044; 391131; 381050; 381054; 391180; 381045; 391177; 391189; 381047; 381051; 381055; 391182; 391157; 391148; 391135; 391143; 391141; 391138; 391175; 391144; 391161; 391150; 391156.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Units are sold to hospitals, clinics, and clinical laboratories thoughout the US. There are 10 VA hospitals. There is one government agency, NIH, Bethesda, MD.
  • Product Description
    COBAS TaqMan Analyzer
  • Manufacturer
    Roche Molecular Systems Inc

Manufacturer

Roche Molecular Systems Inc
  • Manufacturer Address
    Roche Molecular Systems Inc, 11 Franklin Ave, Belleville NJ 07109-3501
  • Source
    USFDA