Events

Recall of Roche Online TDM Tobramycin

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
    37795
  • Event Risk Class
    Class 2
  • Event Number
    Z-0918-2007
  • Event Initiated Date
    2007-04-05
  • Event Date Posted
    2007-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51548
  • 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
    Radioimmunoassay, tobramycin - Product Code KLB
  • Reason
    Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: online tdm carbamazepine, online tdm gentamycin, online tdm phenytoin, online dat cocaine ii, online dat methadone ii, online dat opiates ii and online dat thc ii.
  • Action
    Foreign affiliates were notified via email letter dated 4/5/07 requesting that to notify their customers of the need to implement a special wash cycle to prevent reagent carry over.

Device

Roche Online TDM Tobramycin
  • Model / Serial
    Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution ONLY-Australia, Canada and Germany.
  • Product Description
    Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog no. 0464250319011190. (Note: Not distributed within the United States.)
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

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