Class 2 Device Recall NeoMarkers Rabbit Monoclonal antiHuman Cyclin D1 Antibody (Clone SP4)

• Date Initiated by Firm: March 05, 2010
• Date Posted: September 15, 2010
• Recall Status: Terminated on March 21, 2011
• Recall Number: Z-2424-2010
• Recall Event ID: 56320
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• Product: NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific
• Code Information: lots 9104S911A through 9104S911E and 9104S1001A, Catalog number RM-910, Expiration dates November 2011 and January 2012.
• FEI Number: 3000719701
• Recalling Firm/ Manufacturer: Lab Vision Corporation; 47777 Warm Springs Blvd; Fremont CA 94539-7470
• For Additional Information Contact: 412-490-8425
• Manufacturer Reason for Recall: Two lots may be contaminated with Ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
• FDA Determined Cause: Material/Component Contamination
• Action: Thermo Fisher Scientific issued an "Advisory Notice" letter dated March 5, 2010 to all domestic customers and international distributors. The letter described the product, problem and action to be taken. Customers were instructed to: 1) discard the affected lots, and 2) retest specimens using a replacement lot supplied by the firm, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 International distributors were instructed to: 1) place the affected lots and replace with a replacement lot supplied by the firm, and 2) provide customers with copies of the customer letter, and 3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489 For questions, contact Thermo Fisher Scientific at 1-800-828-1628 or 1-510-771-1595.
• Quantity in Commerce: 103 units
• Distribution: Worldwide Distribution: USA, including the states of CA, SC, IL NY, WI, PA, MN, AL, WA, MA, and KS, and the coutnries of Austria, Australia, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Malaysia, the Netherlands, Norway, Pakistan, Poland, Portugal, Russia, the UK, and 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.