Events

Recall of p21 WF1 Ab3 (DCS60.2) 1 ml (0.4 mg/ml)

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
    72537
  • Event Risk Class
    Class 3
  • Event Number
    Z-0322-2016
  • Event Initiated Date
    2015-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141474
  • 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
    Immunohistochemical reagent, antibody (monoclonal or polyclonal) to p63 protein in nucleus of prosta - Product Code NTR
  • Reason
    It was discovered that the labeling of ms-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.
  • Action
    The firm, ThermoFisher Scientific, sent an "URGENT MEDICAL DEVICE RECALL-Lab Vision Corporation" letter dated 10/29/2015 to its customers on 10/30/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to Upon identification of the affected lot, notify Lab Vision of the quantity previously used and the quantity still in inventory; review any associated test results to ensure an accurate diagnosis was able to be made; If routine laboratory use of this product follows the Lab Vision Data Sheet, the antibody may safely be used as is; hold any affected material in quarantine until the new labels are received-affected product may also be returned to Lab Vision, and complete and return the attached Recall Return Response Acknowledgement & Receipt Form via email to: sarah.rickert@thermofisher.com or Fax to: 269-372-2674, Attn: Quality Assurance & Regulatory Affairs Manager. A new label with the correct concentration can be sent upon request, for relabeling of the product at the customers facility. If you have any questions, please contact Quality Assurance & Regulatory Affairs Manager at 269-544-5628 or sarah.rickert@thermofisher.com.

Device

p21 WF1 Ab3 (DCS60.2) 1 ml (0.4 mg/ml)
  • Model / Serial
    Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands.
  • Product Description
    Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) || 1 ml (0.4mg/ml): || Product code: MS-230-P and MS-230P0; || Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. || 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