Events

Recall of chromID Salmonella Agar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by bioMerieux, 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
    66290
  • Event Risk Class
    Class 2
  • Event Number
    Z-0087-2014
  • Event Initiated Date
    2013-09-06
  • Event Date Posted
    2013-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121947
  • 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
  • Reason
    Complaints for salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. this could potentially lead to salmonella colonies not being detected.
  • Action
    Recall letters were issued to the US customers by Biomeriux, Durham, NC on 9/6/2013.

Device

chromID Salmonella Agar
  • Model / Serial
    Lot 1002234210 and 1002300040
  • Distribution
    Nationwide Distribution.
  • Product Description
    chromID Salmonella Agar, Reference No. 43621. || A selective isolation and differentiation medium for the detection of Salmonella in human specimens.
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA