Events

Recall of Legionella BCYE Growth Supplement SR0110C

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
    63584
  • Event Risk Class
    Class 2
  • Event Number
    Z-0801-2013
  • Event Initiated Date
    2012-10-10
  • Event Date Posted
    2013-02-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114256
  • 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
    Supplement, culture media - Product Code JSK
  • Reason
    The product may contain low level microbial contamination which could result in incorrect results.
  • Action
    ThermoFisher Scientific notified customers on October 10, 2012, with a Field Safety Notice letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised use of this lot could result in incorrect results reporting. This notice needs to be passed on to all who need to be aware within your organization. The firm request the information form be faxed back confirming receipt of notice. For further information please contact Technical Support via our main switchboard on +44 (0) 1256 841144.

Device

Legionella BCYE Growth Supplement SR0110C
  • Model / Serial
    Lot 1175209
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution included the states of IL, IN and MI.
  • Product Description
    The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
  • 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