Events

Recall of Device Recall NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lab Vision 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
    56320
  • Event Risk Class
    Class 2
  • Event Number
    Z-2424-2010
  • Event Initiated Date
    2010-03-05
  • Event Date Posted
    2010-09-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93227
  • 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
    Two lots may be contaminated with ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
  • Action
    Thermo Fisher Scientific issued an "Advisory Notice" letter dated March 5, 2010 to all domestic customers and international distributors. The letter described the product, problem and action to be taken. Customers were instructed to: 1) discard the affected lots, and 2) retest specimens using a replacement lot supplied by the firm, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 International distributors were instructed to: 1) place the affected lots and replace with a replacement lot supplied by the firm, and 2) provide customers with copies of the customer letter, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 For questions, contact Thermo Fisher Scientific at 1-800-828-1628 or 1-510-771-1595.

Device

Device Recall NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4)
  • Model / Serial
    lots 9104S911A through 9104S911E and 9104S1001A, Catalog number RM-910, Expiration dates November 2011 and January 2012.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of CA, SC, IL NY, WI, PA, MN, AL, WA, MA, and KS, and the coutnries of Austria, Australia, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Malaysia, the Netherlands, Norway, Pakistan, Poland, Portugal, Russia, the UK, and Turkey.
  • Product Description
    NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Manufacturer Address
    Lab Vision Corporation, 47777 Warm Springs Blvd, Fremont CA 94539-7470
  • Source
    USFDA