Events

Recall of Device Recall SIOOA I (EP I84) Rabbit Monoclonal Antibody

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cell Marque Corporation.

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
    74179
  • Event Risk Class
    Class 2
  • Event Number
    Z-2038-2016
  • Event Initiated Date
    2016-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146611
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Reason
    Cell marque became aware of some lots of siooa i (ep i84) rabbit monoclonal antibody, catalogue numbers 408r-14, 408r-15, and 408r-16, that exhibited an unacceptable ihc test result.
  • Action
    Product recall notifications were sent to customers on May 12, 2016. Letters advised that all unused or partially-used vials be destroyed. Customers should contact customer service for replacement and credit.

Device

Device Recall SIOOA I (EP I84) Rabbit Monoclonal Antibody
  • Model / Serial
    Lot codes: 1335409A 1335409D 1335409B 1335409E 1335409C 1335409F.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
  • Product Description
    SIOOA I (EP I84) Rabbit Monoclonal Antibody; || Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. || Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
  • Manufacturer
    Cell Marque Corporation

Manufacturer

Cell Marque Corporation
  • Manufacturer Address
    Cell Marque Corporation, 6600 Sierra College Blvd, Rocklin CA 95677-4306
  • Manufacturer Parent Company (2017)
    Sigma-Aldrich Co. Llc
  • Source
    USFDA