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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 5600 Integrated System

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  Class 2 Device Recall VITROS 5600 Integrated System see related information
Date Initiated by Firm February 16, 2016
Create Date April 07, 2016
Recall Status1 Terminated 3 on May 30, 2018
Recall Number Z-1348-2016
Recall Event ID 73429
510(K)Number K081543  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110.
Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
Code Information Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		 The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.
FDA Determined
Cause 2		 Process control
Action On February 16, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification notices to their customers via FedEx overnight courier, e-communications and via USPS. Customers are advised that there is no impact to the results generated with an affected system. As a precaution, your Ortho-trained service representative will contact you to schedule an inspection of the wiring within the system at your facility. Following the inspection, reconfiguration of the wiring on your system will be performed if appropriate. Please store a copy of the notification with your user documentation until the wires within your system(s) are inspected. In addition, complete the receipt form to indicate that you have been informed of this anomaly. Please return the form to Joe Falvo via email at confirmationadmin@its.jnj.com or via fax to 1-888-557-3759 or 1-585-453-4110. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311 anytime.
Quantity in Commerce 2,101 Total units (1,043 domestically & 1,058 internationally)
Distribution Worldwide Distribution-US (nationwide) including Puerto Rico and the 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 = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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