Events

Recall of Proteus vulgaris

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microbiologics 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
    45442
  • Event Risk Class
    Class 2
  • Event Number
    Z-0456-2008
  • Event Initiated Date
    2007-10-12
  • Event Date Posted
    2007-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65471
  • 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
    Quality Control for Culture Media Kit - Product Code JTR
  • Reason
    Mislabeled: duopacks of proteus vulgaris contained listeria monocytogenes instead of the labeled proteus vulgaris.
  • Action
    Consignees were initially notified of this recall by a telephone survey. An Urgent Product Recall letter was sent on 10/17/07 explaining the risk to patients. The firm sent replacements of the recalled product on 10/17/07 or 10/18/07, with request for acknowledgement of Recall Notification, and certification of disposal of incorrect product.

Device

Proteus vulgaris
  • Model / Serial
    Lot Number: 691295
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including states of OR, PA, NY, RI, GA, SC, IL, PR, CA, AZ, and NJ, and countries of Japan, France, Colombia, and Brazil.
  • Product Description
    MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; MicroBiologics, St. Cloud, MN 56303. || (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P)
  • Manufacturer
    Microbiologics Inc

Manufacturer

Microbiologics Inc
  • Manufacturer Address
    Microbiologics Inc, 217 Osseo Ave N, Saint Cloud MN 56303-4452
  • Manufacturer Parent Company (2017)
    Microbiologics Inc
  • Source
    USFDA