Events

Recall of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gen Probe 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
    29380
  • Event Risk Class
    Class 3
  • Event Number
    Z-1072-04
  • Event Initiated Date
    2004-06-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33641
  • 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
    Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis - Product Code NDZ
  • Reason
    Reduced stability.
  • Action
    Firm notified all customers by fax and/or overnight letter on June 11, 2004. The notice indicated that users can continue to the MTD product provided that teh Specimen Processing positive cell controls are used according to package insert instructions and valid assay results are obtained. The affected MTD Enzyme Reagent will be replaced with a new lot of reagent.

Device

Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
  • Model / Serial
    Lots affected 305025 308126 309091 311067 308184 312083 403055 404065 405079 406083 406218 306299 308125 309092 308185 308124 310115 306150 309093 305165 311069 312146 401048 403054 403099 404084 406084 312146R 307177 305027 308183 3010378 311066 401104 403084 405074 307177B 305027B 308183B 310378B 305027C 311066B 311066C 401104B 403084B 405074B
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Product Description
    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,
  • Manufacturer
    Gen Probe Inc

Manufacturer

Gen Probe Inc
  • Manufacturer Address
    Gen Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Source
    USFDA