Class 2 Device Recall VITROS 5600 Integrated System

• Date Initiated by Firm: April 06, 2016
• Create Date: June 06, 2016
• Recall Status: Terminated on June 01, 2018
• Recall Number: Z-1914-2016
• Recall Event ID: 73887
• 510(K)Number: K081543
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
• Code Information: Software Version 3.2.2 & below; VITROS 5600 Serial Numbers J56000024 - J56002387; VITROS 5600 (Refurbished) US Serial Numbers: 56000186, 56000308, 56000315, 56000327, 56000339, 56000458, 56000559, 56000718, 56000727, 56000741, 56000747, 56000750, 56000786, 56000792, 56000824, 56001062, 56001235, 56001635, 56001641; Foreign Serial Numbers: 56000147, 56000200, 56000214, 56000245,56000283, 56000330, 56000331, 56000362, 56000377, 56000399, 56000413, 56000416, 56000428, 56000437, 56000438, 56000439, 56000459, 56000463, 56000464, 56000466, 56000515, 56000528, 56000537, 56000555, 56000560, 56000632, 56000642, 56000669, 56000680, 56000749, 56000867, 56001133, 56001135, 56001246, 56001461, 56001482, 56001487, 56001859. Unique Device Identifier No. 10758750002740
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Ms. Jennifer Paine; 908-218-8776
• Manufacturer Reason for Recall: Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
• FDA Determined Cause: Software design
• Action: On 4/6/2016,URGENT PRODUCT CORRECTION NOTIFICATION letters (Ref. CL2016-076, dated 4/06/2016) were sent via FedEx overnight and/or US Postal Service Priority Mail (only to those consignees who provided a PO Box as an address) to all customers who received the affected product and advised them of the issue and the required actions. Follow enclosed instructions to help decrease the probability of the software anomaly until the software update is installed. Discuss any concerns with previously report results with their Laboratory Medical Director to determine the appropriate course of action. Install Software Version 3.2.3 at their earliest convenience. Foreign affiliates were informed of the issue by e-mail on 4/6/2016, and instructed to notify their consignees of the issue and required actions.
• Quantity in Commerce: VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units
• Distribution: Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
• 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 and Original Applicant = Ortho-Clinical Diagnostics, Inc.