Events

Recall of Device Recall AccuProbe MYCOBACTERIUM AVIUM COMPLEX 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
    55432
  • Event Risk Class
    Class 1
  • Event Number
    Z-1437-2011
  • Event Initiated Date
    2008-12-30
  • Event Date Posted
    2011-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90839
  • 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
    Mycobacterium Spp. DNA-Reagents - Product Code LQF
  • Reason
    This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. the affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. possible false negative results.
  • Action
    Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result. With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the amount destroyed on the Customer Response Form. Gen-Probe should be updated via phone, fax, and email information. Customers should then sign and return the completed form to Gen-Probe via fax to 858-410-8250, or scanned and emailed to technicalsupport@genprobe.com. The Technical Support team should be contacted for replacement kits. Technical Support was also available for additional information at 888-484-4747 or technicalsupport@gen-probe.com.

Device

Device Recall AccuProbe MYCOBACTERIUM AVIUM COMPLEX IDENTIFICATION TEST
  • Model / Serial
    Lots (batches): 555767
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
  • Product Description
    Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.
  • Manufacturer
    Gen-Probe Inc

Manufacturer

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