Events

Recall of Device Recall Accuprobe Group B Streptococcus Culture Identification Test,

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
    44958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0145-2008
  • Event Initiated Date
    2007-05-02
  • Event Date Posted
    2007-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64647
  • 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
    Streptococcus Culture Identification Test, - Product Code MDK
  • Reason
    Mispackaging: kits may contain haemophilus influenza probe pouches in addition to group b streptococcus probe pouches.
  • Action
    Gen-Probe notified customers by phone on May 2nd and 3rd, 2007; a recall notice letter was faxed to each customer on May 3rd, 2007 and mailed on May 4th, 2007 via certified mail. The letter describes the packaging error and the remote health hazard risk, and provides instructions for users to return all kits of this lot number.

Device

Device Recall Accuprobe Group B Streptococcus Culture Identification Test,
  • Model / Serial
    Catalog Number 2820B; Lot Number 531379
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT
  • Product Description
    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
  • Manufacturer
    Gen-Probe Inc

Manufacturer

Gen-Probe Inc
  • Manufacturer Address
    Gen-Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Manufacturer Parent Company (2017)
    Hologic, Inc.
  • Source
    USFDA