Events

Recall of Device Recall Estrogen Receptor AB11 (Clone ID5)

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
    67065
  • Event Risk Class
    Class 2
  • Event Number
    Z-0775-2014
  • Event Initiated Date
    2013-12-06
  • Event Date Posted
    2014-01-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124646
  • 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
    Reagents,specific,analyte - Product Code MVU
  • Reason
    Reports that the product is not performing as expected. in house testing showed no staining on breast cancer tissues.
  • Action
    Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator. If you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.

Device

Device Recall Estrogen Receptor AB11 (Clone ID5)
  • Model / Serial
    PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
  • Product Description
    Estrogen Receptor AB-11 (Clone ID5) || Mouse Monoclonal Antibody || 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA || Thermo Fisher Scientific || Anatomical Pathology || Tudor Rd., Manor Park || Rancorn, Cheshire WA7 1TA UK || Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
  • Manufacturer
    Lab Vision Corporation

Manufacturer

Lab Vision Corporation
  • Manufacturer Address
    Lab Vision Corporation, 46117 Landing Pkwy, Fremont CA 94538-6407
  • Source
    USFDA