Events

Recall of Device Recall CD66e, Ab2 (CEA antibody)

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
    73120
  • Event Risk Class
    Class 3
  • Event Number
    Z-0815-2016
  • Event Initiated Date
    2016-01-18
  • Event Date Posted
    2016-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143095
  • 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
    Certain lots of cea/cd66e ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
  • Action
    ThermoFisher sent an Urgent Medical Device recall letter dated January 18, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed if they have any of the affected product to contact Lab Vision with the information requested on the attached Acknowledgment Form. ¿ Upon identification of the affected lot, please notify Lab Vision of the quantity previously used and the quantity still in inventory. ¿ If any of the above listed lots were previously used, please review test results to ensure a valid result was obtained. If a valid result was obtained, no further action is required. If high background staining was seen, standard IHC troubleshooting guidance for high background staining can be used. (See RISK TO HEALTH section of the letter.) ¿ Affected product may be returned to Lab Vision. Please indicate on the Acknowledgement Form whether the product will be returned. Upon receipt of the form, RGA information will be sent for product requiring return. ¿ If it is preferred to destroy the product at the customer site, please indicate this on the Acknowledgement form. ¿ Please use the attached Recall Return Response Acknowledgement & Receipt Form. Customers with questions were instructed to call 269-544-5628.

Device

Device Recall CD66e, Ab2 (CEA antibody)
  • Model / Serial
    Product Code: RB-368-R7; RB368-R1, Lot Number 368R1407A 368R1407C 368R1407D 368R1407E, all with expiry dates of July 2016. Product code: RB368-R1, Lot Number 368R1407B.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
  • Product Description
    CEA / CD66e Ab-2, Product code RB-368-R7, RB-368-R1; 7 ml each. || Description  Carcinoembryonic antigen (CEA), is synthesized during development in the fetal gut, and is re-expressed in increased amounts in intestinal carcinomas and several other tumors. Antibody to CEA is reportedly useful in identifying the origin of various metastatic adenocarcinomas and in distinguishing pulmonary adenocarcinomas (60-70% are CEA+) from pleural mesotheliomas (rarely or weakly CEA+). || This product 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