Events

Recall of Device Recall ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay

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
    29677
  • Event Risk Class
    Class 3
  • Event Number
    Z-1373-04
  • Event Initiated Date
    2002-07-18
  • Event Date Posted
    2004-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34333
  • 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
    Antigens, All Types, Escherichia Coli - Product Code GMZ
  • Reason
    A potential contamination was noted in the conjugate in the prospect shiga toxin e. coli microplate assay. the particulate in the conjugate may cause the dropper tip to become plugged.
  • Action
    Remel contacted each customer with a letter, by mail, requesting a count of the affected lots to be returned. Product would be replaced upon customer request.

Device

Device Recall ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay
  • Model / Serial
    918706 918707
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US and OUS.
  • Product Description
    ProSpecT Shiga Toxin E. coli (STEC) Micorplate Assay. Catalog #: 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures.
  • 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