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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS 4600 Chemistry System (VITROS 5, FS System family member)VITROS 5600 Integrated System

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  Class 3 Device Recall VITROS 4600 Chemistry System (VITROS 5, FS System family member)VITROS 5600 Integrated System see related information
Date Initiated by Firm September 29, 2014
Date Posted January 20, 2015
Recall Status1 Terminated 3 on April 03, 2017
Recall Number Z-1004-2015
Recall Event ID 69727
510(K)Number K031924  K063144  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integrated System

1) VITROS 4600 - in vitro quantitative measurement of a variety of analytes, 2) VITROS 5600 - in vitro quantitative, semi-quantitative, and qualitative measurement of analytes
Code Information System Product Code: 1) 6802445, 2) 6802413
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Jennifer Paine
908-218-8190
Manufacturer Reason
for Recall		 Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2.
FDA Determined
Cause 2		 Software Manufacturing/Software Deployment
Action Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated September 29, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed Calibration may not occur when using calibrator barcode labels supplied with VITROS Chemisty Products Calibrator Kit 2. The resolution to this software anomaly will be in a future version of software. Until the new software is installed on their VITROS¿ System, customers were instructed not to use the calibrator barcode labels for VITROS¿ Calibrator Kit 2. Customers were advised that you manually program the calibration. Customers with questions were instructed to contact Customer Technical Services at 1-800-421-3311.
Quantity in Commerce 12 units
Distribution Worldwide Distribution - USA including CO, NC, NJ, NY, PA, MI, WV and Internationally to Canada, Japan and 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
510(K)s with Product Code = JJE and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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