Events

Recall of Device Recall Blood Agar (TSA with 5 Sheep Blood)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel 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
    76846
  • Event Risk Class
    Class 2
  • Event Number
    Z-1888-2017
  • Event Initiated Date
    2017-03-24
  • Event Date Posted
    2017-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154393
  • 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
    Culture media, non-selective and differential - Product Code JSH
  • Reason
    Confirmed complaint of surface contamination of listeria monocytogenes.
  • Action
    On 3/24/2017, the recalling firm sent a recall notice to their customers explaining the reason for the recall and instructing customers to review their stock and discard any affected product. The notice also instructed customers to advise of the recall anyone they may have further distributed the recalled lot to. Attached to the recall notice is a response form which the recalling firm instructed their consignees to fill out and return.

Device

Device Recall Blood Agar (TSA with 5 Sheep Blood)
  • Model / Serial
    101686
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution in the states of : AR, AZ, CO, IA, IL, KS, KY, LA, MI, MO, MS, MT, NC, ND, NE, NM, OH, OK, SD, and TX and Puerto Rico
  • Product Description
    Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 || Product Usage: || Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
  • Manufacturer
    Remel Inc

Manufacturer

Remel Inc
  • Manufacturer Address
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA