Events

Recall of Dryspot (R) Staphytect Plus

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
    50224
  • Event Risk Class
    Class 3
  • Event Number
    Z-1008-2009
  • Event Initiated Date
    2008-10-07
  • Event Date Posted
    2009-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75004
  • 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
    Staphylococcus Aureus Screening Kit - Product Code JWX
  • Reason
    Control and test wells are reversed on some of the reaction cards.
  • Action
    The recalling firm issued Important Medical Device Customer Advisory Notice letters dated 10/7/08 via regular mail to their customers explaining the reason for recall. The letter requested that they review their inventory for the product lots indicated in the letter; discard all of the lot remaining in their inventory; complete and return the Product Inventory Checklist.

Device

Dryspot (R) Staphytect Plus
  • Model / Serial
    Lot J054710, Exp. 2010.04.30
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including MN, MI, IL, and NC.
  • Product Description
    Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. || Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
  • Manufacturer
    Remel, Inc

Manufacturer

Remel, Inc
  • Manufacturer Address
    Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA