Events

Recall of Device Recall TaqMan HBV Analyte Specific Reagent

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
    31161
  • Event Risk Class
    Class 2
  • Event Number
    Z-0983-05
  • Event Initiated Date
    2005-02-14
  • Event Date Posted
    2005-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37275
  • 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
    Reagents, Specific, Analyte - Product Code MVU
  • Reason
    Low level of recombinant hiv dna found in one lot of hbv qs which is a component of one lot of the taqman hbv asr.
  • Action
    Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.

Device

Device Recall TaqMan HBV Analyte Specific Reagent
  • Model / Serial
    TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185; HBV Quantitation Standard (HBV QS) Lot F10513.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    One customers received 14 kits on 1/3/2005. This one customer was LabCorp, 1912 Alexander Drive, Research Triangle Park, NC 27709.
  • Product Description
    TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
  • 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