Events

Recall of Device Recall BD GeneOhm MRSA Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BD Diagnostics (GeneOhm Sciences, 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
    52107
  • Event Risk Class
    Class 2
  • Event Number
    Z-1963-2009
  • Event Initiated Date
    2008-11-11
  • Event Date Posted
    2009-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82105
  • 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
    System, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct sp - Product Code NQX
  • Reason
    Bd diagnostics geneohm (bddg) has determined that the cepheid smartcycler reaction tubes packaged in the bd geneohm mrsa test kits identified above may be defective.
  • Action
    BD Diagnostics GeneOhm began contacting consignees by phone November 17, 2008 followed by a letter dated November 21, 2008 instructing discontinued use of the affected lots. Consignees were also asked to complete and return the enclosed Field Action Verification form. To arrange for product replacement or for further information, contact BD Diagnostics Technical Service at 1-888-436-3646 extension 2.

Device

Device Recall BD GeneOhm MRSA Assay
  • Model / Serial
    Catalog Number: 441242, Lot Numbers: 03T08206, 03T08207, 03T08207a and 03T08221a; and  Catalog Number: 441244, Lot Number: 03T08218.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (CA, IL, IN, KT, MD, ME, MN, MO, MT, NC, NJ, NY, OK, PA, TN, TX, UT, VA, and WI), Belgium and Japan.
  • Product Description
    BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). || For the rapid detection of methicillin resistant MRSA DNA in nasal specimen.
  • Manufacturer
    BD Diagnostics (GeneOhm Sciences, Inc)

Manufacturer

BD Diagnostics (GeneOhm Sciences, Inc)
  • Manufacturer Address
    BD Diagnostics (GeneOhm Sciences, Inc), 6146 Nancy Ridge Dr, San Diego CA 92121
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA