Class 2 Device Recall Estrogen Receptor AB11 (Clone ID5)

• Date Initiated by Firm: December 06, 2013
• Date Posted: January 16, 2014
• Recall Status: Terminated on February 25, 2014
• Recall Number: Z-0775-2014
• Recall Event ID: 67065
• Product Classification: Reagents,specific,analyte - Product Code MVU
• Product: 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.
• Code Information: PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.
• Recalling Firm/ Manufacturer: Lab Vision Corporation; 46117 Landing Pkwy; Fremont CA 94538-6407
• For Additional Information Contact: John Green; 510-979-5000
• Manufacturer Reason for Recall: Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
• FDA Determined Cause: Under Investigation by firm
• 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.
• Quantity in Commerce: 5
• Distribution: Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
• 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.