Events

Recall of Device Recall BD GeneOhm MRSA

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
    49470
  • Event Risk Class
    Class 2
  • Event Number
    Z-0226-2009
  • Event Initiated Date
    2008-07-21
  • Event Date Posted
    2008-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73505
  • 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 - Product Code NQX
  • Reason
    Bd diagnostics geneohm (bddg) initiated the recall after they identified that the product has the potential to identify a patient as falsely positive for colonization with methicillin resistant staphylococcus aureus. the potential health hazard related to a false positive result from this assay would be that a patient may be misclassified as having mrsa colonization when in fact they do not have.
  • Action
    BD Diagnostics GeneOhm (BDDG) initial recall notification was made on 07/21/2008 by telephone and followed up with written notification on 07/22/2008. Domestic customers were advised to check their stock to determine if they have inventory remaining of the recalled lot. If so, BD GeneOhm Technical Service will arrange for return of unused product from the customer. The were provided with a Recall Verification form to complete and return. The customers were instructed if they have remaining tests from the affected referenced lot, please discontinue use immediately. They were also told that BD GeneOhm recommend that they review the results of samples tested using this lot of product. Look for any trends outside of the normal expected results, including any changes in MRSA positivity rates compared to your normal prevalence. If they have any questions or concerns following the review, please contact BDDG Technical Service to arrange for consultation with our Medical Director. An telephone number 1-858-334-6356 was given for customers to contact BDDG Technical Service.

Device

Device Recall BD GeneOhm MRSA
  • Model / Serial
    Lot 03T08099 and 03T08099a
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to FL, NJ, NY, OH & PA and Internationally to Belgium
  • Product Description
    BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorgenic target-specific hybridization probes for the detection of amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.
  • 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