Events

Recall of Remel Chocolate Agar

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
    30154
  • Event Risk Class
    Class 3
  • Event Number
    Z-0024-05
  • Event Date Posted
    2004-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35276
  • 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, Enriched - Product Code KZI
  • Reason
    The product does not perform as intended with some quality control organisms (haemophilus influenzae).
  • Action
    The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.

Device

Remel Chocolate Agar
  • Model / Serial
    Lot #435902, Exp. 2004-11-04
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was made to medical facilities and laboratories located in IA, KS, MO, FL, NY, IL, AR, TX, and OK.
  • Product Description
    Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.
  • Manufacturer
    Remel, Inc.

Manufacturer

Remel, Inc.
  • Manufacturer Address
    Remel, Inc., 12076 Santa Fe Trail Dr, (PO Box 14478, zip 66285-4478), Lenexa KS 66215-3519
  • Source
    USFDA