Events

Recall of Device Recall Cytyc ThinPrep

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

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
    25529
  • Event Risk Class
    Class 3
  • Event Number
    Z-0922-03
  • Event Initiated Date
    2003-01-29
  • Event Date Posted
    2003-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25981
  • 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
    Slides, Microscope - Product Code KEW
  • Reason
    Microscope slides contaminated with fungal material.
  • Action
    On 1/29/03 the firm issued a letter advising users of the problem and requesting they cease using the slides for preparation of non-gynecological cytology specimens. Replacement product has been shipped.

Device

Device Recall Cytyc ThinPrep
  • Model / Serial
    Lot Numbers: 4392, 4492, 4592, 4692, 4792, 4892, 4992, 5092, 5192, 5292, and 0293
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    ThinPrep Microscope Slides for Non-Gynecologic Use || Size 1'' x 3'' || Reorder Number: 70214-001
  • Manufacturer
    Cytyc Corporation

Manufacturer

Cytyc Corporation
  • Manufacturer Address
    Cytyc Corporation, 85 Swanson Road, Boxborough MA 01719
  • Source
    USFDA