Events

Recall of Device Recall BD Phoenix PMIC107

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
    77370
  • Event Risk Class
    Class 2
  • Event Number
    Z-0171-2018
  • Event Initiated Date
    2017-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155855
  • 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, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Reason
    Bd has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin b (imlsb) test contained on lot 7031818 of phoenix panels. the imlsb resistance d-test screen for staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. as the product should not be used when quality control (qc) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform qc testing and uses the panel, there is a potential to incorrectly treat a staphylococcus infection with clindamycin based on the imlsb test result. this issue can be detected 100% of the time when used per package insert instructions with imlsb positive strain s. aureus baa-977.
  • Action
    URGENT PRODUCT RECALL LETTER (dated May 2017) were sent to customers via a UPS mailing on May 11, 2017. Customers were instructed to discontinue use of the affected lot and discard any remaining product. BD will replace the discarded inventory. Please complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Please complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or e-mail to: BDRC2@bd.com. For further assistance, please contact BD (Customer/Technical) Support at 1-800-638-8663 in the USA.

Device

Device Recall BD Phoenix PMIC107
  • Model / Serial
    Lot 7031818, Exp. Date 2/28/2018
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CT, VA, PA, TX, FL, NC, WI, NM
  • Product Description
    BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. || PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. --- Product is packaged 25 panels to 1 box.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA