Events

Recall of Device Recall 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
    53553
  • Event Risk Class
    Class 2
  • Event Number
    Z-0818-2010
  • Event Initiated Date
    2009-07-20
  • Event Date Posted
    2010-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85853
  • 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
    Kit, screening, staphylococcus aureus - Product Code JWX
  • Reason
    The products may give false positive results with some non-staphylococcus aureus strains.
  • Action
    Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail. For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.

Device

Device Recall Staphytect Plus
  • Model / Serial
    100-test boxes - Lot Numbers: J539110, Exp. Nov 2009, and J591710, Exp. Jan 2010;  500-test boxes - Lot Numbers: J577920, Exp. Jan 2010; and J610620, Exp. May 2010
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
  • Product Description
    Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK. || Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides 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