Class 3 Device Recall CD66e, Ab2 (CEA antibody)

• Date Initiated by Firm: January 18, 2016
• Date Posted: February 17, 2016
• Recall Status: Terminated on June 24, 2016
• Recall Number: Z-0815-2016
• Recall Event ID: 73120
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: 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.
• Code Information: 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.
• 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: Certain lots of CEA/CD66e Ab2 were produced with a dilution factor of 1:100 instead of the recommended 1:250.
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: RB-368-R7 - 30; RB-368-R1 -2
• Distribution: Worldwide Distribution - US including CA, NY, GA, MS, PA, MA, TX, KY, AZ. and Internationally to Greece, France, Germany, Singapore and Serbia.
• 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.