Events

Recall of Device Recall Staphaurex Plus Kit

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
    51131
  • Event Risk Class
    Class 2
  • Event Number
    Z-1400-2009
  • Event Initiated Date
    2008-11-18
  • Event Date Posted
    2009-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78760
  • 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
    Antistreptolysin - Titer/Streptolysin O Reagent - Product Code GTQ
  • Reason
    These lots may exhibit false positive reactions with strains of staphylococcus epidermidis that may result in the mis-identification of staphylococcus aureus.
  • Action
    Consignees were notified of the recall via letter dated 11/20/08 explaining the reason for recall and requesting any remaining units from the lots be discarded. A Product Inventory Checklist was enclosed to report the amount of product remaining in their inventory. Any non-responding consignees were contacted via telephone during the period of 12/30/08 to 1/11/09 to ensure the effectiveness of the recall. When the recall was expanded to include additional lots, the recalling firm issued an Important Medical Device Customer Recall Notice letters dated 3/16/09 again explaining the reason for recall. The letter also asked consignees to review their inventories for the product lots indicated and requested that remaining units from the lots be discarded. This letter also had a Product Inventory Checklist enclosed for completion.

Device

Device Recall Staphaurex Plus Kit
  • Model / Serial
    Lot No. J311510, Expiry Date 2009.04.30, and Lot J477610, Expiry Date 2009.10.31;  Lot No. J311610, Expiry Date 2009.04.30; Lot No. J477710, Expiry Date 2009.10.31; and J359510, Expiry Date 2009.07.31
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Product Description
    Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England.
  • Manufacturer
    Remel, Inc

Manufacturer

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