Events

Recall of Roche VALP2

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
    37796
  • Event Risk Class
    Class 2
  • Event Number
    Z-0920-2007
  • Event Initiated Date
    2007-04-30
  • Event Date Posted
    2007-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51551
  • 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
    Enzyme immunoassay - Product Code LEG
  • Reason
    Probe wash: reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: creatinine kinase l and creatine kinase-mbl.
  • Action
    Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays.

Device

Roche VALP2
  • Model / Serial
    Lots 144107, exp. 9/30/2007; 144166, exp. 1/31/2008, and 144208, exp. 6/30/2008
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
  • Source
    USFDA