Events

Recall of Device Recall BD MAX GBS

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
    59359
  • Event Risk Class
    Class 2
  • Event Number
    Z-3220-2011
  • Event Initiated Date
    2011-05-24
  • Event Date Posted
    2011-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103202
  • 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
    Medical device bar code reader does not function as intended and could result in associating clinical test results to wrong patient.
  • Action
    BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated May 2011, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customers. The letter advised customers to discontinue use of the Sample Preparation Reagent tubes in the referenced kits and discard any remaining products. Customers were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to (410) 316-4258. For further assistance regarding replacements contact BD Customer Service Dept. 1-800-675-0908. For all other inquiries, contact BD Technical Services Dept. 1-800-638-8663.

Device

Device Recall BD MAX GBS
  • Model / Serial
    Lot numbers 103271, 103272, 110071, 110072, 110391, 110401, 110521, 110522, 110561, 110562, 110181, 110611, 110941, 110942, 111111
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
  • Product Description
    BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. || The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens.
  • 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