Class 2 Device Recall VITROS 5,1 FS Chemistry System

• Date Initiated by Firm: May 06, 2013
• Date Posted: July 02, 2013
• Recall Status: Terminated on May 16, 2018
• Recall Number: Z-1647-2013
• Recall Event ID: 65207
• 510(K)Number: K031924
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
• Code Information: Serial numbers: 1) J34000240, J34000714, J34001562 and J34002163 through J34002245, 2) 34000193, 34000420, 34000478, 34000495, 34000497, 34000529, 34000596, 34000799, 34000805, 34000947, 34001243, 34001422, 34001504, 34001569, 34001589, 34001610, 34001633
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• Manufacturer Reason for Recall: There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.
• FDA Determined Cause: Device Design
• Action: Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letters dated May 6, 2013 and response forms to all affected customers. Ortho Clinical Diagnostics informed their customers of the issue and advised if they detect the smell of melting plastic or observe smoke originating from your VITROS System, to immediately power down the system and contact OCD for assistance. They were also advised to consider performing the backup procedure more frequently to help prevent the loss of data on their Systems. In the near future, an OCD Field Engineer will contact customers who are affected and perform a Modification (MOD) procedure that will replace their potentially affected Wire Connector(s). Foreign affiliates were informed by email on May 6, 2013 of the issue and instructed to notify their customers of the issue and actions. OCD also found that this wire connector is commonly used in many types of computers (i.e., medical devices, personal computers, etc.). On 29 May 2013, OCD expanded their recall to incllude ORTHO Assay Software (OAS) Servers. As a precaution, OCD sent notifications to encompass all ORTHO Assay Software (OAS) Servers that potentially contain this type of wire connector. The letters (Ref. CL13-154) were sent via US Priority Mail to all customers who were shipped an affected OAS Server. Ortho Clinical Diagnostics has requested that customers with any questions or in need of additional information, please call Customer Technical Services at 1-800-421-3311.
• Quantity in Commerce: Total 101 units (84 units for # 6801375- 26 units domestic & 58 units foreign) and (17 units for # 6801890-15 units domestic, 2 units foreign)
• Distribution: Worldwide Distribution - USA Nationwide including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI & WV, and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, PR, 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 = JJE