Events

Recall of Device Recall AmpliChip CYP450

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
    37585
  • Event Risk Class
    Class 2
  • Event Number
    Z-0734-2007
  • Event Initiated Date
    2007-03-09
  • Event Date Posted
    2007-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50895
  • 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
    Drug Metabolizing Enzyme Genotyping System - Product Code NTI
  • Reason
    The current package insert for the amplichip cyp 450 test, lists an incorrect part number for dnase i. the dnase is listed in the "other materials required" section as 'dnase i rec., rnase-free, p/n 04716728001 (roche applied science)" . the part number listed for the dnase i listed is incorrect and of lower specific activity than the correct/validated dnase.
  • Action
    A product advisory notice was issued on March 9, 2007 to all affiliates, indentifying the problem and listing corrective actions followed by a customer letter (Urgent Medical Device Correction) issued on 3/21/2007, requesting several actions be performed including discontinued use of incorrect DNAse I.

Device

Device Recall AmpliChip CYP450
  • Model / Serial
    US Distribution: Model Number: 4591402190 (US-IVD) Batches: H08499, H10626, H13592, J00807, J00815.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide Distribution --- USA including states of MI, IN, NC, CA KY, IN, VA, and FL.and countries of Netherlands, Germany, Sweden, Denmark, Italy, Spain, Belgium, Switzerland, and Hungary
  • Product Description
    AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics
  • Manufacturer
    Roche Molecular Systems, Inc.

Manufacturer

Roche Molecular Systems, Inc.
  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA