Events

Recall of Vysis LSI p16 (9p21)/CEP 9 (9p11q11) Dual Color Probe Set

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

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
    33825
  • Event Risk Class
    Class 3
  • Event Number
    Z-0416-06
  • Event Initiated Date
    2005-10-28
  • Event Date Posted
    2006-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42506
  • 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
    Dna-Probe, Human Chromosome - Product Code MAO
  • Reason
    The dna-probe has a target size of ~300 kb region instead of the labeled ~190 kb region.
  • Action
    Abbott Molecular sent letters dated October 2005 to their direct laboratory accounts on 10/28/05 via first class certified mail. The accounts were informed of the discrepancy between the actual size and region of coverage produced by the affected lots and that described in the product literature. The accounts were instructed to assess the impact of this discrepancy on the use of the product in their laboratory and to retain a copy of the letter with any of the affected product remaining in their inventory.

Device

Vysis LSI p16 (9p21)/CEP 9 (9p11q11) Dual Color Probe Set
  • Model / Serial
    order number 32-190078, lots 42919, 45942, 53417, 57026, 59938, 60858
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore
  • Product Description
    Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078
  • Manufacturer
    Abbott Molecular

Manufacturer

Abbott Molecular
  • Manufacturer Address
    Abbott Molecular, 1300 E Touhy Ave, Des Plaines IL 60018
  • Source
    USFDA