Class 3 Device Recall p21 WF1 Ab3 (DCS60.2) 1 ml (0.4 mg/ml)

• Date Initiated by Firm: October 27, 2015
• Create Date: November 20, 2015
• Recall Status: Terminated on July 07, 2016
• Recall Number: Z-0322-2016
• Recall Event ID: 72537
• Product Classification: Immunohistochemical reagent, antibody (monoclonal or polyclonal) to p63 protein in nucleus of prosta - Product Code NTR
• Product: 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.
• Code Information: Product code: MS-230-P; lot 230P1409A, Expiry 9-2016; Product code: MS-230-P0; lot 230P1409C, Expiry 9-2016.
• Recalling Firm/ Manufacturer: Lab Vision Corporation; 46117 Landing Pkwy; Fremont CA 94538-6407
• For Additional Information Contact: Sarah Rickert; 269-544-5628
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling design
• 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.
• Quantity in Commerce: 5 vials
• Distribution: Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.