Recall of Device Recall Oxoid Legionella BCYE Growth Supplement SR0110A

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Use of the product may not provide adequate recovery and could result in false negative identification of legionella pneumophila.
  • Action
    ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the consignees of the recall and the associated risk of false negative identification of Legionella pneumophila. The consignees were instructed to notify any personnel who need to be aware of the potential for false negative id. of Legionella spp. Further, the consignees were instructed to discard any affected product remaining in their inventory and review all results reported using the recalled lot. The recalling firm requested the consignees complete and return the Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product. If the affected lot was further distributed, the consignees were instructed to notify those entities of the recall and provide a copy of the recall notification letter. If you have any questions, please contact our Technical Services Department at 800.255.6730 (US) or 913.888.0939 ( International)


  • Model / Serial
    Lot No. 1545171
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Distribution to the states of : MI, ND, SC, TN, and TX.
  • Product Description
    Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
  • Manufacturer


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