Class 2 Device Recall VITROS Immunodiagnostic Products CA 125 II Calibrators

• Date Initiated by Firm: October 09, 2013
• Date Posted: December 17, 2013
• Recall Status: Terminated on May 17, 2018
• Recall Number: Z-0525-2014
• Recall Event ID: 66496
• 510(K)Number: K983875
• Product Classification: Test, epithelial ovarian tumor-associated antigen (ca125) - Product Code LTK
• Product: VITROS CA 125 II Calibrators; ; For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or heparin).
• Code Information: product code: 680 0034; Lot numbers 1220, 1230, 1240, 1250
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• Manufacturer Reason for Recall: Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Ortho Clinical Diagnostics, sent a "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated October 9, 2013 to their clients/customers informing them of a shift in results that may be observed when performing patient sample correlation tests between VITROS CA 125 II Calibrators and Reagent Packs. The letter described the product, problem and actions to be taken. The customers were informed that it is acceptable to continue using any remaining inventory until its expiration date providing that quality control results are within acceptable limits (Note: Lots 1220 and 1230 are expired). The customers were also instructed to consider the need to review patient results using the affected lot(s). If you suspect that a previously reported result may have been affected, provide this information to your Laboratory Medical Director and the requesting physician or health care provider so that appropriate actions may be taken for the patients; Complete and return the attached Confirmation of Receipt form no later than October 18, 2013 via FAX TO: Ortho Clinical Diagnostics at 1-888-557-3759 or 1-585-453-4110, and Forward the information in this notification if you have distributed this product outside of your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.
• Quantity in Commerce: 601 units
• Distribution: Worldwide Distribution: US (nationwide) including states of: AK, CA, CT, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, WY, and Puerto Rico, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
• 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.

• 510(K) Database: 510(K)s with Product Code = LTK and Original Applicant = Ortho-Clinical Diagnostics, Inc.