Events

Recall of Device Recall BD MAX MRSA Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

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
    68991
  • Event Risk Class
    Class 2
  • Event Number
    Z-2618-2014
  • Event Initiated Date
    2014-07-23
  • Event Date Posted
    2014-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129213
  • 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
    The performance of the assay no longer conforms to this statement in the analytical specificity section of the package insert: one hundred-eleven (111) out of 111 mssa strains tested at extremely high concentrations (> 106 cfu/swab), produced negative results with the bd max mrsa assay. one of the samples tested with each of the cap surveys mrs5-a 2014 and mrs5-b 2014 yielded false positive results.
  • Action
    Becton Dickinson sent an Field Correction Notification initiated on July 23, 2014. US customers were contacted via letters sent by UPS. The letter identified the product the problem and the action needed to be taken by the customer. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 10% of non-respondents to verify receipt of the customer letter. Any product returned to BD will be quarantined and discarded. Nonetheless, you may observe some false positive results for MSSA strains when using the above referenced product. Please contact the BD Technical Service Department at 1-800-638-8663 if you have observed an increase in MSSA false positive results or have failed the above referenced CAP surveys.

Device

Device Recall BD MAX MRSA Assay
  • Model / Serial
    All Lots with the expiration date January 21, 2014 or later
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.
  • Product Description
    The BD MAX MRSA Assay, catalogue #442953. || An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA